Výsledky vyhledávání - "Regan L Asay"

Review of the Food and Drug Administration's Center for Drug Evaluation and Research Program for New Molecular Entities: Trends and Regulatory Requirements in Acknowledgment Letters and Filing Communications

Autor: Regan L Asay, Scott D. Beattie, Richard Hoffman, Jillian Venci Fuhs, Jennifer Riddle Camp

Publikováno v: Therapeutic innovationregulatory science. 55(3)

The United States Food and Drug Administration (FDA) implemented the PDUFA V New Molecular Entity (NME) Program (the Program) in 2012 to promote greater transparency and increased communication between the FDA review team and applicants of NME New Dr

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::3cfd33668bd2a744f8f13737dca629e6
https://pubmed.ncbi.nlm.nih.gov/33492633

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