FDA grants accelerated approval for Genentechs Rozlytrek (entrectinib) for treating cancers in patients having the specific genetic defect NTRK gene f...
FDA and Syapse announce a multi-year research effort to look at use of real-world evidence in oncology regulatory decisions.
Federal Register notice: FDA posts a draft guidance on gastroparesis drug development.
Federal Register notice: FDA makes available a final guidance entitled Child-Resistant Packaging Statements in Drug Product Labeling.
Forbes Technology Council member Charles Aunger questions whether FDA is able to provide needed oversight of artificial intelligence/machine learning-...
FDA adds three questions and answers to the laboratory controls section of a guidance on current good manufacturing practices.
PhRMA makes general and detailed recommendations for changes to an FDA draft guidance on continuous manufacturing quality considerations.
Federal Register notice: FDA seeks comments on an information collection revision for Protection of Human Subjects; Informed Consent; and Institutiona...