Food and Drug Omnibus Reform Act: A Critical Course Correction
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Publisher
Elsevier BV
Reference9 articles.
1. National Academies of Sciences. Engineering, and Medicine. Improving Representation in Clinical Trials and Research: Building Research Equity for Women and Underrepresented Groups. The National Academies Press; 2022. Accessed December 25, 2023. doi:10.17226/26479.
2. Regulation of Biological Products, 42 USC §262 (2011).
3. Innovation and competition: will biosimilars succeed?: the creation of an FDA approval pathway for biosimilars is complex and fraught with hazard. yes, innovation and market competition are at stake. but so are efficacy and patient safety;Blackstone;Biotechnol Healthc,2012
4. Evaluation of trials comparing single-enantiomer drugs to their racemic precursors: a systematic review;Long;JAMA Netw Open,2021
5. The FDA struggle to withdraw Makena: problems with the accelerated approval process;Aaron;JAMA,2022
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