drug approval

Summary

Summary: Process that is gone through in order for a drug to receive approval by a government regulatory agency. This includes any required pre-clinical or clinical testing, review, submission, and evaluation of the applications and test results, and post-marketing surveillance of the drug.

Top Publications

  1. doi FDA drug approval summary: bevacizumab (Avastin) as treatment of recurrent glioblastoma multiforme
    Martin H Cohen
    Division of Biological Oncology Products, Office of Oncology Drug Products, Center for Drug Evaluation and Research, U S Food and Drug Administration, Silver Spring, Maryland 20993 0002, USA
    Oncologist 14:1131-8. 2009
  2. ncbi The price of innovation: new estimates of drug development costs
    Joseph A DiMasi
    Tufts Center for the Study of Drug Development, Tufts University, 192 South Street, Suite 550, Boston, MA 02111, USA
    J Health Econ 22:151-85. 2003
  3. ncbi Can the pharmaceutical industry reduce attrition rates?
    Ismail Kola
    Basic Research at Merck Research Labs, 126 East Lincoln Avenue, Rahway, New Jersey 07075, USA
    Nat Rev Drug Discov 3:711-5. 2004
  4. doi The US Orphan Drug Act: rare disease research stimulator or commercial opportunity?
    Olivier Wellman-Labadie
    Division of Dermatology, Department of Medicine, University of British Columbia, 835 West 10th Ave, Vancouver, BC, Canada
    Health Policy 95:216-28. 2010
  5. ncbi FDA drug approval summary: bevacizumab plus FOLFOX4 as second-line treatment of colorectal cancer
    Martin H Cohen
    Division of Biological Oncology Products, Office of Oncology Drug Products, Center for Drug Evaluation and Research, US Food and Drug Administration, HFD 150, 5600 Fishers Lane, Rockville, Maryland 20857, USA
    Oncologist 12:356-61. 2007
  6. ncbi Economics of new oncology drug development
    Joseph A DiMasi
    Tufts Center for the Study of Drug Development, Tufts University, Boston, MA 02111, USA
    J Clin Oncol 25:209-16. 2007
  7. ncbi FDA drug approval summary: bevacizumab (Avastin) plus Carboplatin and Paclitaxel as first-line treatment of advanced/metastatic recurrent nonsquamous non-small cell lung cancer
    Martin H Cohen
    Division of Biological Oncology Products, Office of Oncology Drug Products, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland 20993 0002, USA
    Oncologist 12:713-8. 2007
  8. doi Adaptive licensing: taking the next step in the evolution of drug approval
    H G Eichler
    European Medicines Agency, London, UK
    Clin Pharmacol Ther 91:426-37. 2012
  9. ncbi Unknown risks of pharmacy-compounded drugs
    Larry D Sasich
    J Am Osteopath Assoc 108:86. 2008
  10. ncbi Bad bugs need drugs: an update on the development pipeline from the Antimicrobial Availability Task Force of the Infectious Diseases Society of America
    George H Talbot
    Talbot Advisors, Wayne, Pennsylvania, USA
    Clin Infect Dis 42:657-68. 2006

Research Grants

  1. PARS inhibitor therapy for smoke inhalation
    Andrew Salzman; Fiscal Year: 2004
  2. Human Embryonic Stem Cell-Derived Cardiomyocytes for In Vitro Drug Screening
    Jia Qiang He; Fiscal Year: 2007
  3. PNA FOR STROKE
    CARLETON HSIA; Fiscal Year: 2007
  4. The Place of Race in Gene Patenting and Drug Development
    Jonathan Kahn; Fiscal Year: 2007
  5. Pharmacotherapy for Minor Depression
    Robert Howland; Fiscal Year: 2004
  6. MUTATIONS, HORMONE THERAPY, AND VENOUS THROMBOEMBOLISM
    Bruce Psaty; Fiscal Year: 2001
  7. Pharmacogenetics and Cardiovascular Events
    Bruce Psaty; Fiscal Year: 2006
  8. CHS Events Follow-up Study
    Bruce Psaty; Fiscal Year: 2007
  9. CHS Events Follow-up Study
    Bruce M Psaty; Fiscal Year: 2010
  10. Trends in and Outcomes of Medication Use in Older Adults
    Bruce Psaty; Fiscal Year: 2004

Detail Information

Publications202 found, 100 shown here

  1. doi FDA drug approval summary: bevacizumab (Avastin) as treatment of recurrent glioblastoma multiforme
    Martin H Cohen
    Division of Biological Oncology Products, Office of Oncology Drug Products, Center for Drug Evaluation and Research, U S Food and Drug Administration, Silver Spring, Maryland 20993 0002, USA
    Oncologist 14:1131-8. 2009
    ..g., CNS hemorrhage, wound-healing complications, and thromboembolic events) to either bevacizumab, underlying disease, or both could not be determined because of the single-arm, noncomparative study design...
  2. ncbi The price of innovation: new estimates of drug development costs
    Joseph A DiMasi
    Tufts Center for the Study of Drug Development, Tufts University, 192 South Street, Suite 550, Boston, MA 02111, USA
    J Health Econ 22:151-85. 2003
    ..When compared to the results of an earlier study with a similar methodology, total capitalized costs were shown to have increased at an annual rate of 7.4% above general price inflation...
  3. ncbi Can the pharmaceutical industry reduce attrition rates?
    Ismail Kola
    Basic Research at Merck Research Labs, 126 East Lincoln Avenue, Rahway, New Jersey 07075, USA
    Nat Rev Drug Discov 3:711-5. 2004
  4. doi The US Orphan Drug Act: rare disease research stimulator or commercial opportunity?
    Olivier Wellman-Labadie
    Division of Dermatology, Department of Medicine, University of British Columbia, 835 West 10th Ave, Vancouver, BC, Canada
    Health Policy 95:216-28. 2010
    ..This study investigates issues associated with the United States Orphan Drug Act...
  5. ncbi FDA drug approval summary: bevacizumab plus FOLFOX4 as second-line treatment of colorectal cancer
    Martin H Cohen
    Division of Biological Oncology Products, Office of Oncology Drug Products, Center for Drug Evaluation and Research, US Food and Drug Administration, HFD 150, 5600 Fishers Lane, Rockville, Maryland 20857, USA
    Oncologist 12:356-61. 2007
    ....
  6. ncbi Economics of new oncology drug development
    Joseph A DiMasi
    Tufts Center for the Study of Drug Development, Tufts University, Boston, MA 02111, USA
    J Clin Oncol 25:209-16. 2007
    ..Review existing studies and provide new results on the development, regulatory, and market aspects of new oncology drug development...
  7. ncbi FDA drug approval summary: bevacizumab (Avastin) plus Carboplatin and Paclitaxel as first-line treatment of advanced/metastatic recurrent nonsquamous non-small cell lung cancer
    Martin H Cohen
    Division of Biological Oncology Products, Office of Oncology Drug Products, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland 20993 0002, USA
    Oncologist 12:713-8. 2007
    ....
  8. doi Adaptive licensing: taking the next step in the evolution of drug approval
    H G Eichler
    European Medicines Agency, London, UK
    Clin Pharmacol Ther 91:426-37. 2012
    ....
  9. ncbi Unknown risks of pharmacy-compounded drugs
    Larry D Sasich
    J Am Osteopath Assoc 108:86. 2008
  10. ncbi Bad bugs need drugs: an update on the development pipeline from the Antimicrobial Availability Task Force of the Infectious Diseases Society of America
    George H Talbot
    Talbot Advisors, Wayne, Pennsylvania, USA
    Clin Infect Dis 42:657-68. 2006
    ....
  11. pmc Old drugs--new uses
    J K Aronson
    Br J Clin Pharmacol 64:563-5. 2007
  12. doi Evolution of the physicochemical properties of marketed drugs: can history foretell the future?
    Bernard Faller
    Novartis Institutes for BioMedical Research, Basel, Switzerland
    Drug Discov Today 16:976-84. 2011
    ..In this new territory, semi-empirical rules derived from knowledge accumulated from historic, older molecules are not necessarily valid and different liabilities become more prominent...
  13. doi Bridging the efficacy-effectiveness gap: a regulator's perspective on addressing variability of drug response
    Hans Georg Eichler
    European Medicines Agency, London, UK
    Nat Rev Drug Discov 10:495-506. 2011
    ..Successful approaches will not be limited to the current notion of pharmacogenomics-based personalized medicines, but will also entail the wider use of electronic health-care tools to improve drug prescribing and patient adherence...
  14. ncbi FDA drug approval summary: pegaspargase (oncaspar) for the first-line treatment of children with acute lymphoblastic leukemia (ALL)
    Patricia Anne Dinndorf
    U S Food and Drug Administration, White Oak Campus, 10903 New Hampshire Avenue, Building 22, Room 2102, Silver Spring, Maryland 20993 0002, USA
    Oncologist 12:991-8. 2007
    ..Disclosure of potential conflicts of interest is found at the end of this article...
  15. ncbi Prospects for productivity
    Bruce Booth
    McKinsey and Company, 55 East 52nd Street, New York, NY 10055, USA
    Nat Rev Drug Discov 3:451-6. 2004
  16. ncbi FDA drug approval summary: erlotinib (Tarceva) tablets
    Martin H Cohen
    Division of Oncology Drug Products, Center for Drug Evaluation and Research, US Food and Drug Administration, HFD 150, 5600 Fishers Lane, Rockville, Maryland 20857, USA
    Oncologist 10:461-6. 2005
    ..In the first-line treatment of NSCLC, two large, controlled, randomized trials showed no benefit from adding erlotinib to doublet, platinum-based chemotherapy. Therefore, erlotinib is not indicated for use in this setting...
  17. pmc Cancer pharmacogenomics and pharmacoepidemiology: setting a research agenda to accelerate translation
    Andrew N Freedman
    National Cancer Institute, National Institutes of Health, Bethesda, MD 20892 7393, USA
    J Natl Cancer Inst 102:1698-705. 2010
    ....
  18. ncbi Key factors in the rising cost of new drug discovery and development
    Michael Dickson
    College of Pharmacy, University of South Carolina, Columbia, South Carolina 29208, USA
    Nat Rev Drug Discov 3:417-29. 2004
  19. pmc Effectiveness of antidepressants: an evidence myth constructed from a thousand randomized trials?
    John P A Ioannidis
    Clinical Trials and Evidence Based Medicine Unit, Department of Hygiene and Epidemiology, University of Ioannina School of Medicine and the Biomedical Research Institute, Foundation for Research and Technology Hellas, Ioannina, Greece
    Philos Ethics Humanit Med 3:14. 2008
    ....
  20. ncbi The ongoing regulation of generic drugs
    Richard G Frank
    Harvard Medical School, Boston, USA
    N Engl J Med 357:1993-6. 2007
  21. ncbi Food and Drug Administration drug approval summary: Sunitinib malate for the treatment of gastrointestinal stromal tumor and advanced renal cell carcinoma
    Edwin P Rock
    Food and Drug Administration, Division of Drug Oncology Products, 10903 New Hampshire Avenue, Bldg 22, Rm 2133, Silver Spring, Maryland 20903, USA
    Oncologist 12:107-13. 2007
    ..Caution should be exercised when administering sunitinib in combination with known CYP3A4 inducers or inhibitors...
  22. doi EU law mandates drug testing in children
    Gunjan Sinha
    J Natl Cancer Inst 100:84-5. 2008
  23. doi Evidence vs. access: can twenty-first-century drug regulation refine the tradeoffs?
    J Woodcock
    Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA
    Clin Pharmacol Ther 91:378-80. 2012
    ..At the same time, prescribers and payers desire more information about drugs at the time they are released to the market. Will new regulatory schemes be able to accommodate these disparate needs?..
  24. pmc An empirical review of major legislation affecting drug development: past experiences, effects, and unintended consequences
    Aaron S Kesselheim
    Brigham and Women s Hospital, Harvard Medical School, Boston, MA 02120, USA
    Milbank Q 89:450-502. 2011
    ..With the development of transformative drugs at a low point, numerous commentators have recommended new legislation that uses supplementary market exclusivity as an incentive to promote innovation in the pharmaceutical market...
  25. doi A regulatory Apologia--a review of placebo-controlled studies in regulatory submissions of new-generation antidepressants
    Hans Melander
    Medical Products Agency, P O Box 26, SE 751 03 Uppsala, Sweden
    Eur Neuropsychopharmacol 18:623-7. 2008
    ..Differences in the percentage of patients experiencing a clinically relevant response should also be demonstrated. In this respect, the approved SSRIs and SNRIs were found superior to placebo, independent of severity of depression...
  26. ncbi European Medicines Agency review of post-authorisation studies with implications for the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance
    Kevin V Blake
    Pharmacovigilance and Risk Management Sector, Patient Health Protection Unit, European Medicines Agency, London, UK
    Pharmacoepidemiol Drug Saf 20:1021-9. 2011
    ....
  27. doi Iloperidone redux: a dissection of the Drug Approval Package for this newly commercialised second-generation antipsychotic
    L Citrome
    Department of Psychiatry, New York University School of Medicine and the Nathan S Kline Institute for Psychiatric Research, Orangeburg, NY, USA
    Int J Clin Pract 64:707-18. 2010
    To describe the contents of a Drug Approval Package and to describe the efficacy and safety of iloperidone for the treatment of schizophrenia.
  28. ncbi The quandary of compounding for MCOs: administrative costs, risks, and waste
    Thomas Kaye
    Blue Cross and Blue Shield, Oklahoma, USA
    Manag Care 12:42-8. 2003
    ....
  29. pmc Worldwide experience with biosimilar development
    Mark McCamish
    Sandoz Biopharmaceuticals, Sandoz International GmbH, Holzkrichen, Germany
    MAbs 3:209-17. 2011
    ....
  30. doi U.S. Food and Drug Administration drug approval: slow advances in obstetric care in the United States
    Deborah A Wing
    Department of Obstetrics Gynecology, University of California, Irvine, Orange, California 92868, USA
    Obstet Gynecol 115:825-33. 2010
    The process for drug approval in the United States is complex and time-consuming. There are comparatively few drugs with U.S...
  31. ncbi U.S. Food and Drug Administration drug approval summaries: imatinib mesylate, mesna tablets, and zoledronic acid
    Martin H Cohen
    Division of Oncology Drug Products, Center for Drug Evaluation and Research, U S Food and Drug Administration, Rockville, Maryland 20857, USA
    Oncologist 7:393-400. 2002
    ..These three drugs represent three different types of drug approval: Gleevec is an accelerated approval and supplemental new drug application (NDA); Mesnex tablets represent an ..
  32. pmc Development of and access to products for neglected diseases
    Joshua Cohen
    Tufts University Center for the Study of Drug Development, Boston, Massachusetts, United States of America
    PLoS ONE 5:e10610. 2010
    ....
  33. doi Availability of comparative efficacy data at the time of drug approval in the United States
    Nikolas H Goldberg
    Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women s Hospital, Harvard Medical School, Boston, MA 02120, USA
    JAMA 305:1786-9. 2011
    ..Comparative effectiveness is taking on an increasingly important role in US health care, yet little is known about the availability of comparative efficacy data for drugs at the time of their approval in the United States...
  34. doi Disease registries and outcomes research in children: focus on lysosomal storage disorders
    Simon Jones
    Willink Unit, Genetic Medicine, Manchester Academic Health Science Centre, Central Manchester University Hospitals NHS Foundation Trust, St Marys Hospital, Manchester, UK
    Paediatr Drugs 13:33-47. 2011
    ..Clinical trials are a pivotal part of the drug approval process; however, they are not always applicable to the diverse populations - including children - that ..
  35. doi Economic issues with follow-on protein products
    Michael Lanthier
    US Food and Drug Administration, Rockville, Maryland 20857, USA
    Nat Rev Drug Discov 7:733-7. 2008
    ..For the years 2013-2015, we estimate that products representing US$20 billion in annual sales--approximately half of all sales in 2006--can be expected to lose patent protection...
  36. pmc Reporting bias in drug trials submitted to the Food and Drug Administration: review of publication and presentation
    Kristin Rising
    School of Medicine, University of California San Francisco, San Francisco, California, USA
    PLoS Med 5:e217; discussion e217. 2008
    ....
  37. doi Comparison of anticancer drug coverage decisions in the United States and United Kingdom: does the evidence support the rhetoric?
    Anne Mason
    Centre for Health Economics, University of York, York, United Kingdom
    J Clin Oncol 28:3234-8. 2010
    ..Coverage decisions that consider cost effectiveness may lead to restrictions in access...
  38. ncbi Priority-setting decisions for new cancer drugs: a qualitative case study
    D K Martin
    Department of Health Policy, Management and Evaluation and Public Health Sciences, M5G 1L4, Ontario, Canada
    Lancet 358:1676-81. 2001
    ..INTERPRETATION: Observing priority-setting decisions and their rationales in actual practice reveals lessons not contained in theoretical accounts...
  39. ncbi United States Food and Drug Administration Drug Approval summary: Gefitinib (ZD1839; Iressa) tablets
    Martin H Cohen
    Division of Oncology Drug Products, Center for Drug Evaluation and Research, United States Food and Drug Administration, Rockville, Maryland 20857, USA
    Clin Cancer Res 10:1212-8. 2004
    ..Accelerated approval regulations require the sponsor to conduct additional studies to verify that gefitinib therapy produces such benefit...
  40. ncbi Financial anatomy of neuroscience research
    E Ray Dorsey
    Department of Neurology, University of Rochester Medical Center, Rochester, NY, USA
    Ann Neurol 60:652-9. 2006
    ..To estimate the level of funding for neuroscience research from federal and industry sources and to examine the therapeutic advances in the neurosciences over the past decade...
  41. ncbi Development of medicines for children in Europe: ethical implications
    Agnes Saint Raymond
    European Medicines Agency, 7 Westferry Circus, Canary Wharf, London E144HB, UK
    Paediatr Respir Rev 6:45-51. 2005
    ..Future European paediatric regulations should encourage the development of medicines in high-quality ethical research and ensure availability of information to the public...
  42. ncbi Biotechnology: identifying advances from the hype
    Robert H Glassman
    Division of Hematology and Medical Oncology, Weill Medical College of Cornell University, New York, New York 10021, USA
    Nat Rev Drug Discov 3:177-83. 2004
  43. ncbi Should pharmacogenomic studies be required for new drug approval?
    M V Relling
    Department of Pharmaceutical Sciences, St Jude Children s Research Hospital, Memphis, Tennessee, USA
    Clin Pharmacol Ther 81:425-8. 2007
    ..more examples being elucidated in the coming decades, dictates that pharmacogenetics be incorporated into the drug approval process...
  44. ncbi FDA drug approval summaries: pemetrexed (Alimta)
    Maitreyee Hazarika
    U S Food and Drug Administration, HFD 150, 5600 Fishers Lane, Rockville, Maryland 20857, USA
    Oncologist 9:482-8. 2004
    ..Patients should also receive corticosteroids with chemotherapy to reduce the risk of skin rashes. Approval was based on superior survival as a clinical benefit...
  45. pmc How can we regulate medicines better?
    Silvio Garattini
    Mario Negri Institute for Pharmacological Research, Via Eritrea 62, 20157 Milano, Italy
    BMJ 335:803-5. 2007
  46. pmc The Food and Drug Administration's deliberations on antidepressant use in pediatric patients
    Laurel K Leslie
    Children s Hospital, Child and Adolescent Services Research Center, San Diego, California 92123, USA
    Pediatrics 116:195-204. 2005
    ..We also provide research, regulation, education, and practice implications for care for children and adolescents who may be eligible for treatment with these medications...
  47. pmc Non-commercial clinical trials of a medicinal product: can they survive the current process of research approvals in the UK?
    L Sheard
    Centre for Research in Primary Care, 71 75 Clarendon Road, Leeds LS2 9PL, England
    J Med Ethics 32:430-4. 2006
    ..The current approvals process could now be hindering non-commercial clinical trials, leading to a loss of important evidence-based medical information...
  48. pmc Predictors of orphan drug approval in the European Union
    Harald E Heemstra
    Division of Pharmacoepidemiology and Pharmacotherapy, Utrecht Institute for Pharmaceutical Sciences, Faculty of Science, Utrecht University, P O Box 80 082, 3508 TB, Utrecht, The Netherlands
    Eur J Clin Pharmacol 64:545-52. 2008
    ..Recent literature discusses factors that may influence the development of new orphan medicinal products in the EU. This study aims to identify predictors for successful marketing authorisation of potential orphan drugs in the EU...
  49. ncbi Placebo response and antidepressant clinical trial outcome
    Arif Khan
    Northwest Clinical Research Center, 1900 116th Avenue NE 112, Bellevue, Washington 98004, USA
    J Nerv Ment Dis 191:211-8. 2003
    ....
  50. doi Emergence of orphan drugs in the United States: a quantitative assessment of the first 25 years
    M Miles Braun
    Office of Orphan Products Development, US Food and Drug Administration, Silverspring, Maryland 20993, USA
    Nat Rev Drug Discov 9:519-22. 2010
    ..The implications of such findings for future development and marketing of therapies for rare diseases are discussed...
  51. doi Folotyn (pralatrexate injection) for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma: U.S. Food and Drug Administration drug approval summary
    Shakun M Malik
    Office of Oncology Drug Products, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA
    Clin Cancer Res 16:4921-7. 2010
    ..as a single agent for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL); it is the first drug approved for this indication...
  52. ncbi Drug approval summaries: arsenic trioxide, tamoxifen citrate, anastrazole, paclitaxel, bexarotene
    M H Cohen
    Division of Oncology Drug Products, Center for Drug Evaluation and Research, U S Food and Drug Administration, Rockville, Maryland 20852, USA
    Oncologist 6:4-11. 2001
    ..Information provided includes rationale for drug development, study design, efficacy and safety results, and pertinent literature references...
  53. doi Translation of rare disease research into orphan drug development: disease matters
    Harald E Heemstra
    Utrecht Institute for Pharmaceutical Sciences, Utrecht University, The Netherlands
    Drug Discov Today 14:1166-73. 2009
    ..Consequently, additional incentives should focus on stimulating the specific needs of rare disease research at disease class level...
  54. doi Safety-related regulatory actions for orphan drugs in the US and EU: a cohort study
    Harald E Heemstra
    Division of Pharmacoepidemiology and Pharmacotherapy, Utrecht Institute for Pharmaceutical Sciences, Faculty of Science, Utrecht University, 3508 TB Utrecht, The Netherlands
    Drug Saf 33:127-37. 2010
    ..Several studies have been conducted on safety-related regulatory actions for drugs, but none of these have specifically focused on orphan drugs...
  55. ncbi FDA drug approval summaries: oxaliplatin
    Amna Ibrahim
    Division of Oncology Drug Products, Center for Drug Evaluation and Research, U S Food and Drug Administration, Rockville, Maryland 20857, USA
    Oncologist 9:8-12. 2004
    ..Approval was based on response rate and on an interim analysis of TTP. No results are available, at this time, that demonstrate a clinical benefit, such as improvement in disease-related symptoms or survival...
  56. ncbi A comparison of new drug availability in Canada and the United States and potential therapeutic implications of differences
    Joel Lexchin
    School of Health Policy and Management, York University, 4700 Keele St, Toronto, Ont, and Emergency Department, University Health Network, Canada
    Health Policy 79:214-20. 2006
    ..This study uses a convenience sample of new drugs marketed in the United States and determines how many of these products are initially unavailable in Canada and their therapeutic value...
  57. ncbi FDA drug approval summary: azacitidine (5-azacytidine, Vidaza) for injectable suspension
    Edvardas Kaminskas
    U S Food and Drug Administration, 5600 Fishers Lane, HFD 150, Rockville, Maryland 20857, USA
    Oncologist 10:176-82. 2005
    ..S. FDA for MDS, has a favorable safety profile and provides a clinical benefit of eliminating transfusion dependence and complete or partial normalization of blood counts and bone marrow blast percentages in responding patients...
  58. ncbi End points in cancer clinical trials and the drug approval process
    Richard L Schilsky
    Clin Cancer Res 8:935-8. 2002
    ..This editorial will review commonly used clinical trial end points and describe their potential advantages and disadvantages to expedite the drug approval process required in the United States.
  59. ncbi Health-related quality of life (HR-QOL) and regulatory issues. An assessment of the European Agency for the Evaluation of Medicinal Products (EMEA) recommendations on the use of HR-QOL measures in drug approval
    G Apolone
    Istituto di Ricerche Farmacologiche Mario Negri, Milano, Italy
    Pharmacoeconomics 19:187-95. 2001
    ..Experts from different disciplines should be involved in the preparation of such documents to assure the necessary technical expertise and the representativeness of the various counterparts...
  60. ncbi Evaluation of drug-induced QT interval prolongation: implications for drug approval and labelling
    M Malik
    Department of Cardiological Sciences, St George s Hospital Medical School, London, England
    Drug Saf 24:323-51. 2001
    ..The regulatory perspective includes careful adaptation of new research findings...
  61. ncbi Impact of pharmacometric reviews on new drug approval and labeling decisions--a survey of 31 new drug applications submitted between 2005 and 2006
    V A Bhattaram
    Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA
    Clin Pharmacol Ther 81:213-21. 2007
    ..The objective of the current report is to assess the role of PM, at the Food and Drug Administration (FDA), in drug approval and labeling decisions...
  62. ncbi A proposal for radical changes in the drug-approval process
    Alastair J J Wood
    Vanderbilt University School of Medicine, Nashville, USA
    N Engl J Med 355:618-23. 2006
  63. ncbi Learning the value of drugs--is rofecoxib a regulatory success story?
    Rebecca S Eisenberg
    University of Michigan Law School, Ann Arbor, USA
    N Engl J Med 352:1285-7. 2005
  64. ncbi BiDil for heart failure in black patients: The U.S. Food and Drug Administration perspective
    Robert Temple
    U S Food and Drug Administration, Silver Spring, Maryland 20993 0002, USA
    Ann Intern Med 146:57-62. 2007
    ....
  65. ncbi Conditional approval: discussion points from the PSI conditional approval expert group
    Kevin Carroll
    PSI Discussion Group on Conditional Approval, AstraZeneca, UK
    Pharm Stat 7:263-9; discussion 270-1. 2008
    ..The use of interim analyses in Phase III for supporting conditional approval raises some challenging issues regarding dissemination of information, maintenance of blinding, potential introduction of bias, ethics, switching, etc...
  66. ncbi Research design features and patient characteristics associated with the outcome of antidepressant clinical trials
    Arif Khan
    Northwest Clinical Research Center, Number 112, 1900 116th Avenue NE, Bellevue, WA 98004, USA
    Am J Psychiatry 161:2045-9. 2004
    ..The authors examined which, if any, research design features and patient characteristics would significantly differ between successful and unsuccessful antidepressant trials...
  67. ncbi Drug discovery: playing dirty
    Simon Frantz
    Nature 437:942-3. 2005
  68. ncbi Food and Drug Administration Drug approval summary: temozolomide plus radiation therapy for the treatment of newly diagnosed glioblastoma multiforme
    Martin H Cohen
    Division of Oncology Drug Products, Center for Drug Evaluation and Research, US Food and Drug Administration, Rockville, Maryland 20857, USA
    Clin Cancer Res 11:6767-71. 2005
    ..1 months (radiotherapy alone). Adverse events during temozolomide treatment included thrombocytopenia, nausea, vomiting, anorexia, constipation, alopecia, headache, fatigue, and convulsions...
  69. pmc Efficacy, safety, and cost of new anticancer drugs
    Silvio Garattini
    Mario Negri Institute for Pharmacological Research, 20157 Milan, Italy
    BMJ 325:269-71. 2002
  70. ncbi An application of the revised CONSORT standards to FDA summary reports of recently approved antidepressants and antipsychotics
    Arif Khan
    Northwest Clinical Research Center, Bellevue, Washington 98004, USA
    Biol Psychiatry 52:62-7. 2002
    ..They are rarely accessed but may have public health utility. Thus, we assessed these reports to evaluate if the clinical data can be used for comparing psychotropics...
  71. ncbi Adopting orphan drugs--two dozen years of treating rare diseases
    Marlene E Haffner
    Office of Orphan Products Development at the Food and Drug Administration, Rockville, MD, USA
    N Engl J Med 354:445-7. 2006
  72. ncbi FDA drug approval summary: panitumumab (Vectibix)
    Ruthann M Giusti
    Office of Oncology Drug Products, Center for Drug Evaluation and Research, U S Food and Drug Administration, Silver Spring, Maryland 20993, USA
    Oncologist 12:577-83. 2007
    ..The most serious adverse events were pulmonary fibrosis, severe dermatologic toxicity complicated by infectious sequelae and septic death, infusion reactions, abdominal pain, hypomagnesemia, nausea, vomiting, diarrhea, and constipation...
  73. pmc Network analysis of FDA approved drugs and their targets
    AVI MA'AYAN
    Department of Pharmacology and Systems Therapeutics, Mount Sinai School of Medicine, New York, New York 10029, USA
    Mt Sinai J Med 74:27-32. 2007
    ..These initial observations allow for development of an integrated research methodology to identify general principles of the drug discovery process...
  74. ncbi Understanding the scientific issues embedded in the generic drug approval process
    L S Welage
    Department of Clinical Sciences, College of Pharmacy, University of Michigan Health System, Ann Arbor 48109 1065, USA
    J Am Pharm Assoc (Wash) 41:856-67. 2001
    To review the major scientific issues embedded in the generic drug approval process.
  75. ncbi Clinical trials for drug approval: a pilot study of the view of doctors at Tokushima University Hospital
    Hiroaki Yanagawa
    Clinical Trial Center for Developmental Therapeutics, Tokushima University Hospital
    J Med Invest 53:292-6. 2006
    ..as investigators, special attention requirements, and the expected role of CRC in clinical trials for drug approval. In addition, the appropriate use of the outpatient clinic was examined...
  76. ncbi BiDil for heart failure in black patients: implications of the U.S. Food and Drug Administration approval
    Kirsten Bibbins-Domingo
    Division of General Internal Medicine, San Francisco General Hospital, University of California, San Francisco, San Francisco, California 94143 1364, USA
    Ann Intern Med 146:52-6. 2007
    ....
  77. ncbi The US orphan drug programme 1983-1995
    S R Shulman
    Tufts Center for the Study of Drug Development, Tufts University, Boston, Massachusetts, USA
    Pharmacoeconomics 12:312-26. 1997
    ....
  78. ncbi European Clinical Trials Directive: responses made to MHRA consultation letter MLX 287
    David J Flavell
    Lancet 362:1415. 2003
  79. doi FDA drug approval summary: alemtuzumab as single-agent treatment for B-cell chronic lymphocytic leukemia
    Suzanne Demko
    P A C, U S Food and Drug Administration, Silver Spring, Maryland 20993, USA
    Oncologist 13:167-74. 2008
    ..No differences in survival were observed. There were no new safety signals identified in patients receiving alemtuzumab. The most serious, and sometimes fatal, toxicities of alemtuzumab are cytopenias, infusion reactions, and infections...
  80. ncbi FDA drug approval summary: pemetrexed for injection (Alimta) for the treatment of non-small cell lung cancer
    Martin H Cohen
    Division of Oncology Drug Products, Center for Drug Evaluation and Research, U S Food and Drug Administration, Rockville, Maryland 20857, USA
    Oncologist 10:363-8. 2005
    ..Of greatest importance, pemetrexed caused significantly less neutropenia, febrile neutropenia, neutropenic infections, and need for granulocyte/macrophage colony-stimulating factors...
  81. ncbi FDA drug approval summary: gefitinib (ZD1839) (Iressa) tablets
    Martin H Cohen
    Division of Oncology Drug Products, Center for Drug Evaluation and Research, U S Food and Drug Administration, Rockville, Maryland 20857, USA
    Oncologist 8:303-6. 2003
    ..Accelerated approval regulations require the sponsor to conduct further studies to verify that gefitinib therapy produces such a benefit...
  82. ncbi Assessing tumor-related signs and symptoms to support cancer drug approval
    Grant Williams
    Division of Oncology Drug Products, CDER FDA, Rockville, Maryland 20852, USA
    J Biopharm Stat 14:5-21. 2004
    ..While prolongation of survival is an obvious end point for new cancer drug approval, the US Food and Drug Administration (FDA) has also utilized end points that evaluate patient symptoms...
  83. doi FDA drug approval summary: lapatinib in combination with capecitabine for previously treated metastatic breast cancer that overexpresses HER-2
    Qin Ryan
    Division of Oncology Drug Products, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland 20993, USA
    Oncologist 13:1114-9. 2008
    ..There was a 2% incidence of reversible decreased left ventricular function in the combination arm...
  84. pmc Quantitative analysis on the characteristics of targets with FDA approved drugs
    Meena K Sakharkar
    ADAMs Lab, Mechanical, Aerospace Engineering, Nanyang Technological University, Singapore
    Int J Biol Sci 4:15-22. 2008
    ..These quantitative characteristics could serve as criteria to search for promising targetable disease genes...
  85. ncbi U.S. Food and Drug Administration Drug Approval Summary: conversion of imatinib mesylate (STI571; Gleevec) tablets from accelerated approval to full approval
    Martin H Cohen
    Division of Oncology Drug Products, Center for Drug Evaluation and Research, U S Food and Drug Administration, Rockville, Maryland 20857, USA
    Clin Cancer Res 11:12-9. 2005
    ..The present review, based on a safety and efficacy report submitted on December 20, 2002, summarizes data applicable to the conversion of these three CML indications to full approval status...
  86. ncbi Failing the public health--rofecoxib, Merck, and the FDA
    Eric J Topol
    Cleveland Clinic Foundation, Cleveland, USA
    N Engl J Med 351:1707-9. 2004
  87. ncbi How useful are unpublished data from the Food and Drug Administration in meta-analysis?
    Catherine H Maclean
    RAND, 1700 Main Street, M 23C, Santa Monica, CA 90407 2138, USA
    J Clin Epidemiol 56:44-51. 2003
    ..07) did not differ significantly or practically. Data from FDA reviews may be a viable data source for systematic reviews and meta-analyses but only after being subjected to the same methodologic scrutiny as published data...
  88. ncbi A new colonialism?--Conducting clinical trials in India
    Samiran Nundy
    Department of Surgical Gastroenterology, Sir Ganga Ram Hospital, New Delhi, India
    N Engl J Med 352:1633-6. 2005
  89. ncbi Trends in antimicrobial drug development: implications for the future
    Brad Spellberg
    Research and Education Institute and Department of Medicine, Harbor University of California, Los Angeles Medical Center, Torrance, California 90502, USA
    Clin Infect Dis 38:1279-86. 2004
    ..Despite the critical need for new antimicrobial agents, the development of these agents is declining. Solutions encouraging and facilitating the development of new antimicrobial agents are needed...
  90. pmc Economic return of clinical trials performed under the pediatric exclusivity program
    Jennifer S Li
    Department of Pediatrics, Duke Clinical Research Institute, Duke University, Durham, NC 27705, USA
    JAMA 297:480-8. 2007
    ..This critique has been a substantial part of congressional debate on the program, which is due to expire in 2007...
  91. ncbi Curbing industry sponsor's incentive to design post-approval trials that are suboptimal for informing prescribers but more likely than optimal designs to yield favorable results
    Benjamin P Falit
    Seton Hall Law Rev 37:969-1049. 2007
  92. ncbi Documenting the rationale and psychometric characteristics of patient reported outcomes for labeling and promotional claims: the PRO Evidence Dossier
    Dennis A Revicki
    Center for Health Outcomes Research, United BioSource Corporation, 7101 Wisconsin Ave, Suite 600, Bethesda, MD 20814, USA
    Qual Life Res 16:717-23. 2007
    ..The PRO Evidence Dossier may also be helpful to industry and academic researchers in identifying further information that will need to be developed to support the clinical development program and the PRO endpoints...
  93. ncbi The FDA Drug Safety Bill: how safe are our drugs?
    Barton Cobert
    Expert Opin Drug Saf 7:343-6. 2008
    ..Some of the events of the past few years are reviewed along with some of the reactions and changes in the FDA and the field of drug safety followed by the author's conclusions and views on the future of drug safety...
  94. doi Drug-review deadlines and safety problems
    Daniel Carpenter
    Department of Government, Faculty of Arts and Sciences, Harvard University, Cambridge, MA 02138, USA
    N Engl J Med 358:1354-61. 2008
    ..Critics have suggested that these deadlines may result in rushed approvals and the emergence of unanticipated safety problems once a product is in clinical use...
  95. doi Marketing off-label uses to physicians: FDA's draft (mis)guidance
    Andy Gass
    Am J Bioeth 8:1-3. 2008
  96. ncbi The federal preemption debate in pharmaceutical labeling product liability actions
    Jodie M Gross
    Harris Beach PLLC, New York, New York, USA
    Tort Trial Insur Pract Law J 43:35-70. 2007
  97. ncbi Balancing government regulation against access to drugs: address to Seton Hall University School of Law, February 16, 2007
    Daniel Meron
    United States Department of Health and Human Services, USA
    Seton Hall Law Rev 37:929-39. 2007
  98. doi FDA guidance on off-label promotion and the state of the literature from sponsors
    Bruce M Psaty
    Cardiovascular Health Research Unit, Department of Medicine, University of Washington, Seattle, Washington, USA
    JAMA 299:1949-51. 2008
  99. ncbi Promoting, improving and accelerating the drug development and approval processes
    A I Graul
    Drug News Perspect 20:45-55. 2007
    ..This article reviews the three programs and provides a capsule view of new developments in these vital areas during the year 2006...
  100. ncbi Confidentiality laws and secrecy in medical research: improving public access to data on drug safety
    Aaron S Kesselheim
    Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women s Hospital, Boston, Massachusetts, USA
    Health Aff (Millwood) 26:483-91. 2007
    ..We suggest regulatory and legislative policy changes regarding how the FDA handles confidential information that can improve understanding of the risks of prescription drugs...
  101. ncbi Pharmaceutical postmarket review: fact or fiction?
    Stephen J Schanz
    Department of Management, Innovation and Entrepreneurship at the College of Management at North Caroline State University, USA
    Food Drug Law J 62:493-500. 2007

Research Grants110 found, 100 shown here

  1. PARS inhibitor therapy for smoke inhalation
    Andrew Salzman; Fiscal Year: 2004
    ..The proposed clinical trial is expected to provide the foundation for FDA orphan drug approval of INO-1001 for treatment of acute smoke inhalation injury.
  2. Human Embryonic Stem Cell-Derived Cardiomyocytes for In Vitro Drug Screening
    Jia Qiang He; Fiscal Year: 2007
    ..The FDA now requires cardiac safety studies prior to drug approval. Since compound development costs a drug company approximately $45,000 per day, identifying candidate drugs ..
  3. PNA FOR STROKE
    CARLETON HSIA; Fiscal Year: 2007
    ..the requirements of the FDA for an Investigational New Drug (IND) application, an essential step to new drug approval. There are three major components for the completion: chemistry manufacturing and control (CMC), GLP toxicity ..
  4. The Place of Race in Gene Patenting and Drug Development
    Jonathan Kahn; Fiscal Year: 2007
    ..a new phenomenon emerging - the implicit use of race and as genetic categories to obtain patent protection and drug approval. The specific objectives of this project are the following: i...
  5. Pharmacotherapy for Minor Depression
    Robert Howland; Fiscal Year: 2004
    ..The results of this study will have profound public health implications by improving our understanding of the efficacy of SJW and standard antidepressants for the treatment of MinorD. ..
  6. MUTATIONS, HORMONE THERAPY, AND VENOUS THROMBOEMBOLISM
    Bruce Psaty; Fiscal Year: 2001
    ....
  7. Pharmacogenetics and Cardiovascular Events
    Bruce Psaty; Fiscal Year: 2006
    ..The primary defense is replication: we would therefore welcome collaboration from others in the Pharmacogenetics Network in validation efforts. ..
  8. CHS Events Follow-up Study
    Bruce Psaty; Fiscal Year: 2007
    ..Additional events follow-up will not only provide the opportunity to address the aims of this study, but also enhance the power of current and future CHS papers and ancillary studies by CHS and non-CHS colleagues. ..
  9. CHS Events Follow-up Study
    Bruce M Psaty; Fiscal Year: 2010
    ..PUBLIC HEALTH RELEVANCE: Additional knowledge about the determinants of cardiovascular health and disease in older adults will help physicians and their patients make diagnostic, prognostic, and therapeutic decisions. PROJECT/ ..
  10. Trends in and Outcomes of Medication Use in Older Adults
    Bruce Psaty; Fiscal Year: 2004
    ..abstract_text> ..
  11. WGA Study to Identify Genetic Variants Associated with CV Events in CHS
    Bruce Psaty; Fiscal Year: 2009
    ..The proposed three-part study is efficient, has excellent power to detect small to modest-sized hazard ratios, provides a large sample of WG scans for aim 2, and includes an external replication. (End of Abstract) ..
  12. EPIDEMIOLOGY OF ANTI-HYPERTENSIVE DRUGS IN THE ELDERLY
    Bruce Psaty; Fiscal Year: 1993
    ..This project will enable us to pursue vigorously a set of related analyses of the effects of anti-hypertensive medicines on a variety of outcomes in the elderly...
  13. Microglia, Complement, and Pain
    Clifford J Woolf; Fiscal Year: 2010
    ..We will use this information to devise and test novel treatment strategies for somatic and facial neuropathic pain based either on blocking complement gene induction in microglia or complement cascade activation in the nervous system. ..
  14. ALTERED SENSIBILITY FOLLOWING PERIPHERAL NERVE DAMAGE
    Clifford J Woolf; Fiscal Year: 2010
    ....
  15. Digoxin Chiral Isolates as Improved Pharmaceuticals
    John Somberg; Fiscal Year: 2005
    ..The advantage would be a treatment for AF that did not cause cardiac augmentation and vasoconstriction or a treatment for CHF that does not cause heart rate slowing or conduction disturbances. ..
  16. Neural Plasticity and Inflammatory Pain
    CLIFFORD WOOLF; Fiscal Year: 2005
    ..Prevention of posttranslational changes may, in addition, offer new approaches for treatment of inflammatory pain hypersensitivity, a major health problem, and we need, therefore, to acquire an integrated view of these phenomena. ..
  17. Potency of cryopreserved, irradiated sporozoite vaccine
    Stephen Hoffman; Fiscal Year: 2005
    ..The project will also provide a method for cryopreserving unirradiated sporozoites that could be used to challenge volunteers by injection with P. falciparum in vaccine studies worldwide. ..
  18. ACYL GLUCURONIDES: COVALENT BINDING & PHARMACOKINETICS
    Leslie Benet; Fiscal Year: 1993
    ..investigate the relationship between irreversible binding in vivo and immunological toxicity...
  19. Lyophilization of Plasmodium falciparum sporozoite vaccine
    Stephen Hoffman; Fiscal Year: 2007
    ..Additionally, a dried vaccine may accelerate a concerted world-wide effort to eradicate this devastating disease. ..
  20. DEFENSIN AND THE PATHOGENESIS OF ATHEROSCLEROSIS
    Douglas Cines; Fiscal Year: 2002
    ..Finally, the interaction between endogenous defensin and endogenous Lp(a) will be examined in a novel transgenic mouse than overexpresses both human defensin and human Lp(a). ..
  21. Innate Effectors of rAls3p-N Anti-Candida Vaccine
    Brad Spellberg; Fiscal Year: 2009
    ..PNS 398/2590 (Rev. 11/07) Page - Continuation Format Page ..
  22. Cranberry for Prevention of Bacteriuria in Pregnancy
    Deborah Wing; Fiscal Year: 2005
    ..We believe that the data to be gathered from this investigation will support a large, Phase I/ll multi-center trial and an R01 application. ..
  23. Phase I Study of ALT-801 in Metastatic Melanoma/Kidney Cancer Patients
    Mayer Fishman; Fiscal Year: 2009
    ....
  24. MARROW REGULATION IN CYCLIC HEMATOPOIESIS
    David Dale; Fiscal Year: 2003
    ....
  25. Mechanisms of Als vaccine protection against S. aureus
    Brad Spellberg; Fiscal Year: 2007
    ..The insights into fundamental immunological mechanisms of protection against S. aureus will also be of extreme importance to the development of other vaccine candidates targeting S. aureus in the future. ..
  26. Quetiapine for the treatment of Type A and Type B alcoholism
    Kyle Kampman; Fiscal Year: 2007
    ..Exploratory analyses will be conducted to further investigate other possible quetiapine / alcohol subtype interactions ..
  27. Investigation of influenza virulence mediated by the NS1A protein
    DIANA NOAH; Fiscal Year: 2007
    ....
  28. Exploratory Trial of Curcumin in Pancreatic Cancer
    Razelle Kurzrock; Fiscal Year: 2005
    ..These studies should provide the foundation for the development of curcumin as an anticancer agent and may lead to a novel approach to the management of pancreatic cancer. ..