FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

CGMP Violations at Lohxa LLC

[ Price : $8.95]

FDA warns Lohxa LLC about CGMP violations in its production of finished pharmaceuticals.

Device-Related Infections Likely Antibiotic-Resistant: Study

[ Price : $8.95]

A Center for Disease Control and Prevention report says that healthcare-associated infections resulting from medical devices are m...

CymaBay Stops Seladelpar Studies Over Safety Concerns

[ Price : $8.95]

CymaBay Therapeutics terminates a Phase 2b study of seladelpar in subjects with non-alcoholic steatohepatitis and its recently ini...

FDA Reopens Tobacco Product Comment Period

[ Price : $8.95]

Federal Register notice: FDA reopens for 20 days the comment period on a 9/25 proposed rule on premarket tobacco product applicati...

Intercept NDA for NASH Drug Accepted

[ Price : $8.95]

FDA accepts for priority review an Intercept Pharmaceuticals NDA for obeticholic acid seeking accelerated approval for treating fi...

New FDA Efforts on Device EtO Sterilization

[ Price : $8.95]

FDA announces its Ethylene Oxide Sterilization Master File Pilot Program that is intended to allow companies that sterilize single...

FDA Guidances for Generic Drug Developers

[ Price : $8.95]

Federal Register notice: FDA makes available additional draft and revised draft product-specific guidances for generic drug develo...

Info Collection for Fellowship/Trainee Programs

[ Price : $8.95]

Federal Register notice: FDA seeks comments on a proposed information collection for Collection of Information for Participation i...

Guide on Insulin Biosimilar Immunogenicity

[ Price : $8.95]

FDA issues a draft guidance on Clinical Immunogenicity Considerations for Biosimilar and Interchangeable Insulin Products.

Renovia Next-Gen Leva Pelvic Therapeutic Cleared

[ Price : $8.95]

FDA clears a Renovia 510(k) for its next-generation Leva Pelvic Digital Therapeutic for strengthening pelvic floor muscles and tre...