Worried about device shortages that could occur from recent closures of facilities that use ethylene oxide to sterilize medical devices, an FDA adviso...
The International Medical Device Regulators Forum issues three final guidances relating to clinical evaluation, clinical evidence, and clinical invest...
FDA medical reviewers ask the Endocrinologic and Metabolic Diseases Advisory Committee to discuss efficacy and safety information on Amarins Vascepa.
FDA releases its latest batch of Warning Letters that includes MSM Nutraceuticals, Cadila Healthcare and Swabplus.
Federal Register notice: FDA submits to OMB an information collection extension for Format and Content Requirements for Over-the-Counter Drug Product ...
Start-up pharmacy Valisure makes a name for itself by chemically validating drugs it purchases from wholesalers before fulfilling prescriptions for co...
Regenxbio files a lawsuit in DC federal court against FDA, challenging a clinical hold on its gene therapy for retinal diseases.
FDA grants AI Medical Service a Breakthrough Device Designation for its artificial intelligence programs that analyze endoscopy images for diagnosing ...