FDA clears a Royal Philips 510(k) for the DigitalDiagnost C90, its newest digital radiography system.
Federal Register notice: FDA issues a final rule to establish criteria for and identify an initial list of bulk drug substances that can be used to co...
FDA and Arca Biopharma reach agreement on a special protocol assessment for a Phase 3 trial of the companys Gencaro to treat atrial fibrillation in ce...
FTC says it has reached a global settlement with Teva to ban two types of reverse-payment patent settlements.
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FDA releases a draft guidance on the process applicants should follow to seek designation of a drug as a competitive generic therapy under the FDA Rea...
Federal Register notice: FDA makes available a draft guidance entitled Nonbinding Feedback After Certain FDA Inspections of Device Establishments.
Federal Register notice: FDA makes available a draft guidance entitled Competitive Generic Therapies that is intended to help expedite the development...