FDA warns United Exchange about CGMP violations at two facilities producing finished pharmaceuticals.
Two stakeholders request changes to an FDA draft guidance on the content of premarket submissions for managing medical device cybersecurity.
FDA issues two guidances to help drug sponsors develop drugs to prevent HIV-infection and to treat HIV in pediatric patients.
FDA clears an Atreon Orthopedics 510(k) for the Rotium Bioresorbable Wick, intended for use in supporting healthy tendon regeneration related to rotat...
FDA asks members of its Neurological Devices Panel to evaluate the safety and effectiveness of Neuronix NeuroAD based on results of a clinical trial t...
A New York grocery workers union sues AbbVie for colluding to delay entry of a biosimilar version of its Humira in the U.S.
FDA releases its latest batch of Warning Letters that include Integra LifeSciences, Mentor Worldwide and Acclarent, Nutra Pharma, Sientra, and United ...
Stokes Healthcare recalls one lot of veterinary-use pilocarpine 0.1% ophthalmic solution because it has been found to contain a higher level of the pr...