FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

24 Drugs not Withdrawn Due to Safety/Efficacy: FDA

[ Price : $8.95]

Federal Register notice: FDA determines that 24 drug products were not withdrawn due to safety or effectiveness reasons.

Panel Mulls Immune Responses with Metal Devices

[ Price : $8.95]

Federal Register notice: FDA announces an 11/13-14 Immunology Devices Panel of the Medical Devices Advisory Committee meeting to d...

Draft Guide on Patient-focused Drug Development

[ Price : $8.95]

Federal Register notice: FDA makes available a draft guidance on Patient-Focused Drug Development: Methods To Identify What Is Imp...

CGMP Violations at South Koreas Dermameal

[ Price : $8.95]

FDA warns South Koreas Dermameal about CGMP violations in its role as a contract manufacturer of finished pharmaceuticals.

$220 Million Sentinel Next Phase Contract Awarded

[ Price : $8.95]

FDA awards a five-year contract that could be worth $220 million to Harvard Pilgrim Health Care Institute for the next phase of th...

FDA Explains Urgent/11 Cybersecurity Vulnerability

[ Price : $8.95]

FDA provides information about the Urgent/11 cybersecurity vulnerability that could affect medical devices.

Endo Claims Win in Vasopressin Compounding Case

[ Price : $8.95]

Endo says it is withdrawing a 2017 suit against FDA over agency enforcement discretion in permitting bulk drug compounding of vaso...

Multiple Repeat Violations in Lupin Inspection

[ Price : $8.95]

FDA warns Lupin about CGMP violations and deviations at one of its units that are similar to those found in other Lupin facilities...

Latest FDA Warning Letters

[ Price : $8.95]

FDA releases its latest batch of Warning Letters that includes Lupin Limited, Shanghai Institute of Pharmaceutical Industry, Derma...

Heron Resubmits NDA for Pain Drug

[ Price : $8.95]

Heron Therapeutics resubmits an NDA for HTX-011, an investigational agent for managing postoperative pain.