Three drug industry stakeholders comment on an FDA draft guidance on developing a shared system risk evaluation and mitigation strategy.
Pharmaceutical Research and Manufacturers of America praises an FDA draft guidance on postmarket surveillance of drugs, biologics, and combination pro...
FDA releases its latest batch of Warning Letters that includes Blaine Labs, Lymol Medical and International Trading Pharm Lab.
FDA accepts for accelerated review an Eiger BioPharmaceuticals NDA for Zokinvy (lonafarnib) for treating Progeria and Progeroid Laminopathies.
Questions are raised about an HHS a contract that could be worth $812 million to Phlow, a start-up drug manufacturing company, to make generic drugs f...
FDA announces a 6/9-10 Web cast entitled Pharmacovigilance and Risk Management Conference New Approaches, Tools, and Technologies.
FDA clears a Zebra Medical Vision 510(k) for its Vertebral Compression Fractures (XXX DELETE XXX)) product, an artificial intelligence solution that a...
FDA warns Lymol Medical about multiple Quality System and Medical Device Reporting violations in its manufacturing of a bronchoscope system and silico...