FDA principal deputy commissioner Amy Abernathy says the agency has an agreement with Aetion to use real-world data to research answers to Covid-19 qu...
FDA warns Indias Kumar Organic Products about CGMP violations in its production of finished pharmaceuticals.
Three drug industry stakeholders comment on an FDA draft guidance on developing a shared system risk evaluation and mitigation strategy.
Pharmaceutical Research and Manufacturers of America praises an FDA draft guidance on postmarket surveillance of drugs, biologics, and combination pro...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 grants an emergency use authorization for Everlywells at-home sample collection kit that can then be sent to laboratories for Covid-19 diagnostic ...