FDA publishes a draft guidance on defining, identifying, and reporting protocol deviations in clinical investigations.
FDA says a Boston Scientific recall updating instructions for two cryoablation balloon catheters is Class 1.
FDA says it will receive comments until 2/28 on a draft guidance on the possibility for cancer drug sponsors and FDA to prepare a joint briefing docum...
FDA warns Akorn Formulations in Hyderabad, Telangana, India, about CGMP violations in its production of over-the-counter drugs for the U.S. market.
CDER updates its CDER NextGen Portal to allow Right to Try annual summary submissions for CDER-regulated products.
FDA posts a final guidance entitled Technical Specifications for Submitting Clinical Trial Data Sets for Treatment of Noncirrhotic Nonalcoholic Steato...
FDA encourages drug sponsors to use centralized statistical monitoring to help keep an eye on clinical trial integrity issues.
McKinsey & Co. agrees to pay $650 million to settle both criminal and civil investigations into its advisory work with Purdue Pharma and the marketing...
