Wird geladen...

US Food and Drug Administration utilization of postmarketing requirements and postmarketing commitments, 2009-2018

BACKGROUND/AIMS: The US Food and Drug Administration (FDA) outlines clinical studies as postmarketing requirements and commitments to be fulfilled following FDA approval of new drugs and biologics (“therapeutics”). Regulators have increasingly emphasized lifecycle evaluation of approved therapeutics...

Ausführliche Beschreibung

Gespeichert in:
Bibliographische Detailangaben
Veröffentlicht in:Clin Trials
Hauptverfasser: Skydel, Joshua J, Zhang, Audrey D, Dhruva, Sanket S, Ross, Joseph S, Wallach, Joshua D
Format: Artigo
Sprache:Inglês
Veröffentlicht: 2021
Schlagworte:
Online Zugang:https://ncbi.nlm.nih.gov/pmc/articles/PMC8292154/
https://ncbi.nlm.nih.gov/pubmed/33863236
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1177/17407745211005044
Tags: Tag hinzufügen
Keine Tags, Fügen Sie den ersten Tag hinzu!