FDA Webview closes its newsroom for the end-of-year Holiday Season, reopening Monday, Jan 5, 2026.
The New York Times reports that ongoing turmoil at FDA has increasingly placed commissioner Marty Makary under the microscope, raising concerns among public health experts and the biotech industry.
FDA Webview closes its newsroom for the end-of-year Holiday Season, reopening Monday, Jan 5, 2026.
The New York Times reports that ongoing turmoil at FDA has increasingly placed commissioner Marty Makary under the microscope, raising concerns among public health experts and the biotech industry.
FDA cites a GlaxoSmithKline biologicals manufacturing site in Hungary for significant lapses in deviation investigations and material controls, including failures to assess worst-case conditions for batches later used in the production of widely used vaccines.
FDA posts two separate Form 483 inspection reports citing a range of quality and compliance deficiencies at Catalent Maryland, Inc., highlighting ongoing challenges in the company’s contract biologics and gene therapy manufacturing.
