Open AccessFDA’s Benefit–Risk Framework for Human Drugs and Biologics: Role in Benefit–Risk Assessment and Analysis of Use for Drug Approvals
Author(s) -
Leila G. Lackey,
Graham Thompson,
Sara Eggers
Publication year - 2020
Publication title -
therapeutic innovation and regulatory science
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.569
H-Index - 44
eISSN - 2168-4804
pISSN - 2168-4790
DOI - 10.1007/s43441-020-00203-6
Subject(s) - drug , context (archaeology) , risk analysis (engineering) , medicine , food and drug administration , pharmacy , human immunodeficiency virus (hiv) , flexibility (engineering) , pharmacology , drug approval , orphan drug , family medicine , bioinformatics , management , paleontology , biology , economics
Structured, descriptive approaches are utilized by drug regulatory agencies to support and communicate approval decisions about human drugs and biologics. The US Food and Drug Administration (FDA) uses the Benefit-Risk Framework (BRF), which has been integrated into its drug review process. This paper reviews how FDA review teams have used the BRF to communicate approval decisions.