FDA releases a 26-page FDA-483 with 12 observations from an inspection at Plattsburgh, NY-based StarRx outsourcing facility.
FDA lists lots of immune globulin intravenous and subcutaneous that have been withdrawn due to reports of allergic/hypersensitivity reactions.
A Trinity Life Sciences white paper on clinical trial diversity says FDA should change its policy and install minimum representation requirements.
Medtronic recalls its TurboHawk Plus Directional Atherectomy System because it is similarly designed as another recently recalled device.
FDA steps up its review of phosphatidylinositol-3-kinase (PI3K) inhibitor safety concerns by convening a 4/21-22 Oncologic Drugs Advisory Committee me...
Federal Register notice: FDA creates a docket to receive comments on changes to the agencys previously proposed quality metrics reporting program.
The Regulatory Affairs Professional Society says FDA and medical device industry representatives have reached an agreement on MDUFA 5.
FDA clears a Cionic 510(k) for its lightweight leg-worn Cionic Neural Sleeve, intended for functional electrical stimulation to assist in gait for peo...