FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Drug Labeling Improved for Pregnant Women: FDA

[ Price : $8.95]

FDA confirms that all drugs now have updated labeling to better provide health risk information to pregnant women.

4 States Want Mifepristone REMS Ended

[ Price : $8.95]

California, Massachusetts, New Jersey, and New York ask FDA to cancel the mifepristone REMS program requirements in their states o...

Makary Pushes for Reductions in Regulatory Barriers

[ Price : $8.95]

FDA commissioner Marty Makary promises that the agency will listen to stakeholder ideas on reducing regulatory barriers and evolvi...

QS Issues at DFI Company

[ Price : $8.95]

FDA warns Koreas DFI Co., Ltd. about Quality System and Medical Device Reporting violations in its manufacturing of reagent strips...

Pay Attention to FDA AI Reviews: Attorneys

[ Price : $8.95]

Three Morgan Lewis attorneys tell regulated product sponsors to watch for AI involvement in FDA reviews and be prepared to respond...

Smiths Issues 3 Recalls on Infusion Pumps

[ Price : $8.95]

FDA announces three Class 1 recalls (device corrections) by Smiths Medical related to certain CADD [computerized ambulatory delive...

CGMP Issues at Huangshi Hygienic

[ Price : $8.95]

FDA warns Chinas Huangshi Hygienec Material Medicine Co. about CGMP violations in its manufacturing of finished drugs.

Vigil Neuro Ends Trial of Rare Brain Disorder Drug

[ Price : $8.95]

Vigil Neuroscience ends its Phase 2 long-term extension study of investigational therapy iluzanebart based on disappointing study ...

Draft Guide on OTC Drug Minor Changes

[ Price : $8.95]

FDA posts a draft guidance entitled Recommendations for Complying With Over-the-Counter Monograph Procedure for Minor Changes C001...

Evi Labs CGMP Violations

[ Price : $8.95]

FDA warns Medley, FL-based Evi Labs about CGMP violations in its work as a contract drug manufacturer.