CDER director Patrizia Cavazzoni says the 2023 Drug Safety Priorities report focuses on the nations drug overdose crisis.
Pharmaceutical Research and Manufacturers of America asks FDA to take some specific follow-up steps to its virtual meeting on advancing the developmen...
FDA increases its educational outreach to decrease hesitancy with biosimilar usage.
FDA grants Mesoblast an orphan-drug designation for Revascor (rexlemestrocel-L) and its use in children with congenital heart condition hypoplastic le...
A Regulatory Affairs Professionals Society online post says FDA is several weeks late in delivering a congressionally mandated guidance on clinical tr...
FDA grants Diamyd Medical a fast-track designation for Diamyd (rhGAD65/alum) and its use in improving glycemic control in some diabetes patients.
FDA clears a Merit Medical Systems 510(k) for the SCOUT MD Surgical Guidance System for use in implanting surgical reflectors in abnormal breast tissu...
FDA makes available a final guidance entitled Charging for Investigational Drugs Under an IND: Questions and Answers.