The European Medicines Agency says FDA has confirmed the capability of five more member states to conduct drug inspections.
Stakeholders praise an FDA draft guidance on adaptive designs for drug and biologic trials and offer some recommendations for improvement.
Several CDER experts report to a drug shortage conference on agency efforts to date to take a fresh look at the drivers of drug shortages and find las...
Federal Register notice: FDA announces a 1/11/2019 joint meeting of the Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Comm...
FDA issues a draft guidance to assist manufacturers in using the Dual 510(k) and CLIA Waiver by Application pathway.
Federal Register notice: FDA announces a 4/10/2019 public meeting entitled Prescription Drug User Fee Act of 2017; Electronic Submissions and Data Sta...
FDA issues 63 new and revised product-specific guidances to promote development of generic drugs.
FDA warns Corona Doctors Medical Clinics about objectionable conditions in its conduct of a clinical investigation.