FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Abbott Diabetes Care QS Violations

[ Price : $8.95]

FDA warns Abbott Diabetes Care about Quality System violations in its production of glucose monitoring systems at a facility in Al...

Repeat CGMP Violations at Kirkman Drug Manufacturing

[ Price : $8.95]

FDA warns the Lake Oswego, OR-based Kirkman drug manufacturing facility about repeat CGMP violations in its production of finished...

12 Observations in Baxter Oncology FDA-483

[ Price : $8.95]

FDA releases the form FDA-483 with 12 observations from an inspection at the Baxter Oncology drug manufacturing facility in Halle,...

Guide on Device Cybersecurity Released

[ Price : $8.95]

FDA posts a final guidance entitled Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submi...

Representative Questions Voucher Program Legality

[ Price : $8.95]

Rep. Jake Auchincloss calls on FDA to affirm or refute his conclusion that the Commissioners National Priority Voucher program may...

FDA Cautious Stance on CAR-T Cell Therapies for Autoimmune Diseases

[ Price : $8.95]

An FDA-authored journal article signals a supportive but cautious regulatory posture toward the development of chimeric antigen re...

Early Alert on Abiomed Impella RP Heart Pumps

[ Price : $8.95]

FDA issues an early alert to warn clinicians about a potentially high-risk issue affecting certain Abiomed heart pump devices used...

FDA Officials Personal Legal Actions Trigger Ethics Probe

[ Price : $8.95]

HHS Office of Inspector General begins an ethics investigation into FDA deputy chief of staff Samuel Doran and whether he misled t...

Floridas FDA-Authorized Canadian Drug Import Program Stalls

[ Price : $8.95]

Floridas FDA-authorized drug importation program stalls and has yet to deliver any imported medicines more than two years after re...

Warning Letter Sent to Beta Bionics

[ Price : $8.95]

FDA issues Beta Bionics a Warning Letter following an inspection of the companys Irvine, CA, facility conducted 6/2025.