FDA warns Stratus Biosystems that it is illegally marketing biological products whose manufacturing has significant deviations from CGMP requirements.
FDA says the Teva and Apotex generic forms of Vandas Hetlioz do not violate labeling requirements or raise safety concerns due to some different eleme...
FDA approves a Tarsus Pharmaceuticals NDA for Xdemvy (lotilaner ophthalmic solution) 0.25% for treating Demodex blepharitis, an eyelid disease caused ...
CDRH announces new standards recognized by the agency to improve medical device sterilization.
An FDA podcast reports ways in which the CURE ID app is being expanded beyond infectious diseases.
Federal Register notice: FDA makes available a final guidance entitled M7(R2) Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmac...
FDA releases the form FDA-483 with 12 observations from an inspection at the Bloomington, IN-based Catalent Indiana sterile drug and biologic product ...
Three stakeholders raise concerns about an FDA draft guidance on using generally accepted scientific knowledge in drug and biologic applications.
