Federal Register notice: CDER announces a 4/3 public workshop entitled CDER and You: Keys to Effective Engagement.
Medtronic begins a Class 1 recall of its Cardiac Resynchronization Therapy with Defibrillation and Implantable Cardiovert-Defibrillators due to a defe...
Federal Register notice: FDA makes available a guidance on Q11 Development and Manufacture of Drug Substances Questions and Answers (Chemical Entitie...
FDA, the Centers for Disease Control and Prevention, and the American Society for Microbiology announce the availability of voluntary, standardized du...
FDA Review posts the Federal Register notices for the week ending 2/23/2018.
Federal Regiser notice: FDA withdraws approval of 24 ANDAs from multiple applicants because the products are no longer marketed.
FDA releases an FDA-483 issued after an inspection at a Hospira sterile drug manufacturing plant.
Avalere Health identifies three steps it says FDA can take to facilitate interchangeable biosimilar applications and approvals.