FDA approves a TransMedics PMA for the Organ Care System Lung platform for use in standard double lung transplants.
Harvard Medical School researchers say the meaning of the FDA breakthrough therapy designation can mislead patients and their doctors.
Kaiser Health News reports that the FDA Office of Criminal Investigations is looking into the activities of a late Southern Illinois University profes...
FDA says Haemonetics is recalling 18 lots of Acrodose Plus and PL systems due to report of low pH readings for platelets in some lots.
Federal Register notice: FDA makes available a draft guidance entitled Expansion of the Abbreviated 510(k) Program: Demonstrating Substantial Equivale...
FDA issues two final guidances to aid development of next generation sequencing-based diagnostic tests.
HHS and the Justice Department issue a report on the FY 2017 healthcare fraud and abuse control program.
FDA approves a Novartis NDA for Afinitor Disperz (everolimus tablets for oral suspension) for the adjunctive treatment of adult and pediatric patients...