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Innovation, Regulation, and the FDA | NEJM
- https://www.nejm.org/doi/full/10.1056/NEJMsa1007467
- The FDA can become more transparent, so that knowledge and insights can be shared and the field of drug discovery can move forward more quickly. Regulatory …
Regulating Off-Label Drug Use — Rethinking the …
- https://www.nejm.org/doi/full/10.1056/NEJMp0802107
- The Food and Drug Administration (FDA) provides a barrier to market entry and use of unproven and unsafe products. …
FDA Approval and Regulation of Pharmaceuticals, 1983 …
- https://pubmed.ncbi.nlm.nih.gov/31935033/
- Conclusions and relevance: Over the last 4 decades, the approval and regulation processes for pharmaceutical agents have evolved and increased in …
Emerging Regulatory Affairs Trends in 2022
- https://www.northeastern.edu/graduate/blog/regulatory-affairs-trends/
- Regulatory affairs professionals play an essential role within the lifecycle of drugs, biologics, and medical devices, helping …
Regulation and Innovation: Role of Regulatory Science …
- https://pubmed.ncbi.nlm.nih.gov/30883715/
- Regulatory science is defined as science and research intended to inform decision making in a regulatory framework. This issue of Clinical Pharmacology & Therapeutics and the …
FDA Approval and Regulation of Pharmaceuticals, 1983 …
- https://jamanetwork.com/journals/jama/fullarticle/2758605
- After the 1962 Kefauver-Harris Drug Amendments prohibited marketing without explicit FDA approval based on documentation of efficacy, budget limitations made it impossible for …
Advancing Regulatory Science at FDA - Food and …
- https://www.fda.gov/media/145001/download
- FDA advances regulatory science by developing the tools and methods, and obtaining the data needed to speed innovation, improve regulatory evaluation, and facilitate availability …
Pharmaceuticals Regulation - an overview
- https://www.sciencedirect.com/topics/pharmacology-toxicology-and-pharmaceutical-science/pharmaceuticals-regulation
- Pharmaceutical regulations, or medicines regulations, have been defined as the combination of legal, administrative, and technical measures that governments …
FDA Regulation of Medical Devices—Moving Beyond the …
- https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2786216
- Increased awareness of the harms of limited US Food and Drug Administration (FDA) regulation led to the first statutory premarket regulation of medical devices. Full Text …
Fact Sheet: FDA at a Glance | FDA - U.S. Food and …
- https://www.fda.gov/about-fda/fda-basics/fact-sheet-fda-glance
- About 78 percent of active pharmaceutical ingredients manufacturers are located outside of the U.S. FDA-regulated products account for 15 percent of U.S. imports …
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