An 8/2021 FDA outsourcing facility inspection of Eagle Pharmacy (Hoover, AL) results in a five-page Form FDA 483 that cited several GMP deficiencies.
FDA approves a Pfizer NDA for Cibinqo (abrocitinib), an oral Janus kinase 1 inhibitor for treating certain adults living with refractory, moderate-to-...
FDA clears a Nextremity Solutions 510(k) for its InCore Subtalar System, indicated for reduction and internal fixation of arthrodeses, osteotomies, an...
A new Government Accountability Office report says FDA needs better planning for its recruitment and retention of medical product staff.
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...