FDA releases its latest batch of Warning Letters that includes High Chemical, Indoco Remedies and Stratus BioSystems.
FDA says Bayer is recalling two lots of Kogenate FS because some vials contained its Jivi antihemophilic factor rather than Kogenate.
FDA approves a Pfizer BLA for Ruxience (rituximab-pvvr), a biosimilar to Biogens Rituxan for three indications.
FDA posts a final guidance on Postmarketing Safety Reporting for Combination Products.
FDA approves nine ANDAs for first generics of Pfizers Lyrica for managing neuropathic pain associated with diabetic peripheral neuropathy, and for man...
Federal Register notice: FDA sends to OMB a proposed information collection for quick turnaround surveys on communication effectiveness.
Federal Register notice: FDA releases a list of 10 information collections that have been approved by OMB.
Federal Register notice: FDA submits to OMB an information collection extension for Bar Code Label Requirement for Human Drug and Biological Products....