Janssen raises issues from an FDA draft guidance on quality considerations for continuous manufacturing for further clarification and explanation.
Stakeholders suggest changes to an FDA draft guidance on a risk-based approach to monitoring clinical investigations.
FDA clears an Aidoc 510(k) for its pulmonary embolism artificial intelligence product that helps radiologists flag and triage embolisms in chest compu...
A new study finds that drug companies often conducted clinical trials after winning FDA approval, but most were not related to the approved use unless...
Federal Register notice: FDA makes available a final guidance entitled Considerations in Demonstrating Interchangeability With a Reference Product.
FDA clears a Haemonetics 510(k) to expand the medical indication of its TEG 6s Hemostasis Analyzer System for use in adult trauma settings.
FDA warns Bershtel Enterprises about CGMP violations in its production of finished drugs as a contractor to its customers.
The Supreme Court says whistleblowers in cases where the federal government does not intervene can have a longer period of time in which to file their...