Federal Register notice: FDA announces a 3/10 virtual public hearing on scientific data and information related to the residue of carcinogenic concern...
FDA releases the FDA-483 with four observations from an inspection at Fenton, MO-based SSM St. Clare Health Center.
FDA updates its 12/2020 safety communication on Endologixs AFX endovascular graft systems used in treating abdominal aortic aneurysms and the risks as...
FDA approves Mentors MemoryGel Boost Breast Implant for breast augmentation in women at least 22 years old, and for women of all ages undergoing breas...
A physician and a trade association executive say FDA requirements for using Covid-19 antiviral drugs will work against people who could benefit from ...
FDA puts a clinical hold on Denali Therapeutics DNL919 IND for Alzheimers.
FDA releases nine safety summaries for materials that are commonly used in implantable medical devices.
GlaxoSmithKline and Vir ask FDA to allow intramuscular administration of their Covid-19 monoclonal antibody treatment sotrovimab.