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FDA warns Stratus Biosystems that it is illegally marketing biological products whose manufacturing has significant deviations fro...[ Price : $8.95]
FDA says the Teva and Apotex generic forms of Vandas Hetlioz do not violate labeling requirements or raise safety concerns due to ...[ Price : $8.95]
FDA approves a Tarsus Pharmaceuticals NDA for Xdemvy (lotilaner ophthalmic solution) 0.25% for treating Demodex blepharitis, an ey...[ Price : $8.95]
CDRH announces new standards recognized by the agency to improve medical device sterilization.[ Price : $8.95]
An FDA podcast reports ways in which the CURE ID app is being expanded beyond infectious diseases.[ Price : $8.95]
Federal Register notice: FDA makes available a final guidance entitled M7(R2) Assessment and Control of DNA Reactive (Mutagenic) I...[ Price : $8.95]
FDA releases the form FDA-483 with 12 observations from an inspection at the Bloomington, IN-based Catalent Indiana sterile drug a...[ Price : $8.95]
Three stakeholders raise concerns about an FDA draft guidance on using generally accepted scientific knowledge in drug and biologi...