FDA issues an alert against the use of certain Baxter Solution Sets with Duo-Vent Spikes because they were incorrectly assembled with inverted slide c...
FDA issues a complete response letter for Zealands glepaglutide intended to treat short bowel syndrome.
FDA warns a Viatris Mylan drug manufacturing facility in Pradesh, India, about CGMP violations involving quality and data issues.
FDA adds a liver injury Boxed Warning to labeling for Astellas menopause hot flash drug Veozah.
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...
