FDA issues a draft guidance to help applicants comply with content and format requirements for drug label subsections on pregnancy, lactation, and peo...
FDA issues a guidance on using pathological complete response as an endpoint for accelerated approval of drugs to treat high-risk early-stage breast c...
The Justice Department says Pacira Pharmaceuticals is paying $3.5 million to resolve a whistleblower charge that it provided kickbacks to doctors to i...
FDA clears a Neocis 510(k) for a new Yomi edentulous indication for its robot-assisted dental surgery system.
FDA updates its inactive ingredient database to allow users to perform electronic queries to obtain accurate maximum daily exposure information for ex...
FDA tells the GAO that a provision in the CARES Act should help it address more quickly safety issues in OTC drugs.
Federal Register notice: FDA withdraws approval of Hikma International Pharmaceuticals no-longer-marketed abbreviated new animal drug application for ...
FDA posts a draft guidance entitled Setting Endotoxin Limits During Development of Investigational Oncology Drugs and Biological Products.