FDA denies a Zydus petition asking the action to take actions about the indomethacin suppository reference standard.
FDA releases the form FDA-483 with nine observations from an inspection at Indias Eugia Pharma Specialties sterile drug manufacturing facility.
Citius Pharmaceuticals resubmits a BLA for Lymphir (denileukin diftitox) for treating patients with relapsed or refractory cutaneous T-cell lymphoma.
Regarding safety, the most common side effects of Aurlumyn include headache, flushing, heart palpitations, fast heart rate, nausea, vomiting, dizzines...
Smiths Medical ASD recalls its Medfusion model 4000 syringe pump due to issues associated with earlier software versions.
FDA posts a final guidance entitled Charging for Investigational Drugs Under an IND Questions and Answers.
Federal Register notice: FDA announces the continuation of its Regulatory Project Management Site Tours and Regulatory Interaction Program.
An FDA advisory committee votes 13 to 1 that the benefits of Abbott's TriClip transcatheter edge-to-edge repair system outweighs the risks for treatin...
