FDA grants Medtronic a breakthrough device designation for its investigational Personalized Closed Loop insulin pump system.
FDA releases its latest batch of Warning Letters that include Mark Berman and Datascope.
FDA warns Dr. Reddys Laboratories about multiple violations at its Telangana, India, drug manufacturing facility.
FDA releases a draft guidance on the process applicants should follow to seek designation of a drug as a competitive generic therapy under the FDA Rea...
Federal Register notice: FDA makes available a draft guidance entitled Nonbinding Feedback After Certain FDA Inspections of Device Establishments.
Federal Register notice: FDA makes available a draft guidance entitled Competitive Generic Therapies that is intended to help expedite the development...
Federal Register notice: FDA posts a final guidance entitled Expedited Programs for Regenerative Medicine Therapies for Serious Conditions.
Federal Register notice: FDA makes available a final guidance entitled Evaluation of Devices Used with Regenerative Medicine Advanced Therapies that p...