Two stakeholders request changes to an FDA draft guidance on the content of premarket submissions for managing medical device cybersecurity.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 ...
FDA warns two breast implant manufacturers about deficiencies in their mandated post-approval studies of device long-term safety and risks.
Federal Register notice: FDA seeks comments on an information collection extension for Medical Devices: Use of Symbols in Labeling Glossary to Suppor...