Federal Register notice: FDA makes available a draft guidance on Referencing the definition of device in public documents.
Federal Register notice: FDA classifies the traumatic brain injury eye movement assessment aid into medical device Class 2 (special controls).
Biogen says it will submit a final clinical trial protocol to FDA 3/2022 for a required post-marketing trial of its controversial Alzheimers drug Aduh...
FDA denies a petition questioning Eugia Pharmas use of an ANDA for a generic Makena autoinjector.
Oncology Center of Excellence director Richard Pazdur and chief of medical oncology Julia Beaver call for changes in the development process for new c...
FDA denies a Par Sterile Products petition saying it failed to raise valid scientific or regulatory issues and was submitted as a delaying tactic.
FDA posts a draft guidance entitled Inspection of Injectable Products for Visible Particulates.
CDRH Office of Product Evaluation and Quality director William H. Maisel tells an industry conference that the agency is planning to release very soon...