CDRH releases a discussion paper, 3D Printing Medical Devices at the Point of Care, that proposes potential point-of-care manufacturing scenarios for ...
FDA posts an International Council for Harmonization guidance entitled Q3C(R8) Impurities: Guidance for Residual Solvents.
Medtronics Covidien unit recalls its Puritan Bennett 980 Ventilator Series System due to a manufacturing assembly error.
Federal Register notice: FDA withdraws approval of a Fresenius Kabi NDA for Voluven (6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride injection)...
Federal Register notice: FDA posts a draft guidance entitled Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulato...
Federal Register notice: FDA publishes modifications to its list of standards FDA recognizes for use in premarket reviews: Modifications to the List o...
FDA issues a draft guidance on using real-world data and evidence to support NDA and BLA decisions.
FDA publishes a guidance on the types of changes to an approved BLA to be documented in an annual report.