Helpful Webinars and Other Resources for Generic Drug Manufacturers
FDA develops resources – workshops, webinars, and seminars – to help generic drug manufacturers improve the quality of their abbreviated…
Notable Approvals | Drugs
News about human drug-related approvals
FDA approves first treatment for adults with complement 3 glomerulopathy, a rare kidney disease, to reduce proteinuria
FDA approves first treatment for adults with complement 3 glomerulopathy, a rare kidney disease, to reduce proteinuria
Seindni Co., Ltd. – 533363 – 12/05/2017
CGMP/Finished Pharmaceuticals/Adulterated
Developing a Toolkit to Assess Efficacy of Ebola Vaccines and Therapeutics
MCMi regulatory science project to research issues that are key to understanding and predicting if—and how—vaccines and therapeutics to prevent…
Center for Drug Evaluation and Research Organization Chart
Organization chart for the FDA’s Center for Drug Evaluation and Research, including leadership roles.
Guidance and Other Information of Special Interest to MCM Stakeholders
Information of particular interest to sponsors/applicants of medical countermeasures to treat, prevent, diagnose, and detect chemical, biological, radiological, and nuclear…
Guidance Recap Podcast | General Clinical Pharmacology Considerations for Neonatal Studies for Drugs and Biological Products
Guidance Recap Podcast: General Clinical Pharmacology Considerations for Neonatal Studies for Drugs and Biological Products
FDA to Compounders: Know Your Bulks and Excipients Suppliers
FDA has identified several issues over the past few years related to repackers of bulk drug substances, also called active…
GDUFA Implementation Quarterly Meetings between FDA and Industry
FDA and representatives of the generic drug industry meet quarterly to discuss topics related to the implementation of GDUFA.