Document Type
Article
Publication Date
2020
Keywords
Food and Drug Regulation, Regulatory Disagreements
Abstract
Thirty days after a novel therapeutic agent, a new molecular entity, or original biologic is approved, the US Food and Drug Administration (FDA) must publicly disclose its approval package, including scientific reviews completed by FDA disciplines (eg, pharmacology, statistical, and medical reviewers) and any available assessments by agency leadership.1 Although reports of internal disagreement have surfaced,2 it is unclear how often such disagreements occur. Disagreements document differing points of view or engaged discussion and may, thus, capture important scientific debates or signal challenging decisions within the agency. We sought to determine the frequency of disagreements within the FDA regarding approval of novel therapeutic agents.
Creative Commons License
This work is licensed under a Creative Commons Attribution 4.0 International License.
Recommended Citation
Andrea MacGregor et al, "Disagreements Within the US Food and Drug Administration Regarding Approval of Novel Therapeutic Agents, 2011-2015" (2020) 3:7 JAMA Network e209498.
Included in
Food and Drug Law Commons, Health Law and Policy Commons, Medical Jurisprudence Commons, Science and Technology Law Commons
