FDA warns Mechanicsville, VA-based American Contract Systems about Quality System Regulation violations in its manufacturing of sterile convenience ki...
FDA warns Chinas Zhejiang Qimei Cosmetic Co. about CGMP violations in its manufacturing of OTC drugs.
FDA accepts for review an Abeona Therapeutics BLA resubmission for prademagene zamikeracel (pz-cel), a gene therapy for patients with recessive dystro...
Federal Register notice: FDA determines that Nuplazid (pimavanserin tartrate) tablet (equivalent 17 mg base) was not withdrawn due to safety or effect...
Federal Register notice: FDA announces a 12/12 public workshop titled Optimizing the Use of Real-World Evidence in Regulatory Decision-Making for Drug...
House Energy and Commerce Committee Republicans ask for a GAO review of laboratory safety in FDA, CDC, and NIH, citing previous GAO recommendations th...
FDA warns two firms in Taiwan and Australia about Quality System violations in their manufacturing of x-ray equipment.
FDA sends Intercept Pharmaceuticals a complete response letter on its supplemental NDA for Ocaliva (obeticholic acid) seeking to convert its accelerat...
