Product-Specific Regulatory Pathways to Approve Generic Drugs: The Need for Follow-up Studies to Ensure Safety and Effectiveness - PubMed

Generic drugs possessing the same active ingredients, dosage form, strength, route of administration, and labeling can be approved by the US Food and Drug Administration (FDA) as interchangeable with a brand-name drug without needing to repeat the formal Phase I, II, and III clinical trials conducte …

Product-Specific Regulatory Pathways to Approve Generic Drugs: The Need for Follow-up Studies to Ensure Safety and Effectiveness - PubMed Clipboard, Search History, and several other advanced features are temporarily unavailable. Skip to main page content The .gov means it’s official. Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site. The site is secure. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Access ke

saved by

• Eric Feng

related reading

• Canadian and US drug approval times and safety considerations - PubMedpubmed.ncbi.nlm.nih.gov
• Why the FDA Is Slow to Remove Drugspress.asimov.com
• Federal Register :: Platform Technology Designation Program; Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Requestfederalregister.gov
• Clinical Diagnostic Accuracy of Parkinson's Disease: Where Do We Stand? - PubMedpubmed.ncbi.nlm.nih.gov
• ALS Genetics, Mechanisms, and Therapeutics: Where Are We Now? - PubMedpubmed.ncbi.nlm.nih.gov
• Pharmacological Management of Pediatric Pustular Psoriasis - PubMedpubmed.ncbi.nlm.nih.gov
• FDA Announces Major Steps to Implement Real-Time Clinical Trials | FDAfda.gov
• A weight of evidence assessment approach for adverse outcome pathways - PubMedpubmed.ncbi.nlm.nih.gov
• Drug Commercialization Process: From Research to Marketbiotechprimer.com
• Digital Health and Primary Care - Implementing High-Quality Primary Care - NCBI Bookshelfncbi.nlm.nih.gov
• Population pharmacokinetics of palivizumab, a humanized anti-respiratory syncytial virus monoclonal antibody, in adults and children - PubMedpubmed.ncbi.nlm.nih.gov
• America Must Address Early Clinical Developmentfda.gov