Jennifer J Ross

Summary

Affiliation: Food and Drug Administration
Country: USA

Publications

  1. ncbi request reprint Considerations in the development of live biotherapeutic products for clinical use
    Jennifer J Ross
    Division of Vaccines and Related Products Applications, Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, Food and Drug Administration PHS, Rockville, MD, USA
    Curr Issues Mol Biol 10:13-6. 2008
  2. ncbi request reprint Vaccine INDs: review of clinical holds
    Daryll L Miller
    Division of Vaccines and Related Products Applications, Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike, HFM 475 Rockville, MD 20852, USA
    Vaccine 23:1099-101. 2005

Collaborators

Detail Information

Publications2

  1. ncbi request reprint Considerations in the development of live biotherapeutic products for clinical use
    Jennifer J Ross
    Division of Vaccines and Related Products Applications, Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, Food and Drug Administration PHS, Rockville, MD, USA
    Curr Issues Mol Biol 10:13-6. 2008
    ..S. for a specific clinical use. Product information is an important component of an IND to support a proposed clinical study...
  2. ncbi request reprint Vaccine INDs: review of clinical holds
    Daryll L Miller
    Division of Vaccines and Related Products Applications, Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike, HFM 475 Rockville, MD 20852, USA
    Vaccine 23:1099-101. 2005
    ..In addition, sponsors who sought formal pre-IND advice decreased the likelihood of their resulting IND being placed on clinical hold...