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He served as the primary individual responsible for scientific review, policy development and regulation relevant to the safety, efficacy and availability of blood components for transfusion, plasma derivatives (e.g. albumin, clotting factors, immune globulins, etc.), analogous recombinant plasma proteins, and drugs and devices related to manufacture of these products. Under his leadership, the FDA implemented safety controls for for Human Immunodeficiency Virus (HIV), human T-lymphotropic virus (HTLV, HCV, HBV), Hepatitis C, Hepatitis B, Hepatitis A, syphilis, cytomegalovirus (CMV), West Nile virus, Chagas disease, human parvovirus B19, HAV, TSE transmissible spongiform encephalopathies (TSE) agents, Ebola virus, and Zika virus and established standards for approval of AIDS-related diagnostic tests. He licensed or approved more than 100 biologics products and devices based on determinations of their safety and clinical efficacy, and established control programs including biological reference reagents, to assure their purity, potency, and manufacturing consistency.
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He worked in Building 29, Room 324, and in the FDA’s Woodmont Building in Rockville, Maryland.
https://www.who.int/biologicals/expert_committee/BIO_EPSTEIN_Jay_2018.pdf -add to bibliography
https://clinicalcenter.nih.gov/about/news/newsletter/2019/fall/story-19.html -add to bibliography
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