FDA publishes Annex 2 of the International Council on Harmonization Good Clinical Practice guidance.
FDA warns a Canadian Brands International facility about limiting and delaying an inspection that also identified CGMP violations.
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...
FDA clears a Zimmer Biomet 510(k) for the OsseoFit Stemless Shoulder System for total shoulder replacement.
Lawyers on a Food & Drug Law Institute enforcement panel warn that the incoming Trump administration is likely to target and seek increased enforcemen...
