FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Harmonized Benefit/Risk Info Guidance

[ Price : $8.95]

FDA publishes a draft International Conference on Harmonization guidance on enhancing the format and structure of benefit-risk inf...

Issues Raised with FDA PDUFA Meeting Guidance

[ Price : $8.95]

BIO says an FDA draft guidance on formal meetings between the agency and sponsors of PDUFA products will give additional clarity.

FDA Approves BMS Opdivo/Yervoy for Melanoma

[ Price : $8.95]

FDA approves a Bristol-Myers Squibb NDA for Opdivo (nivolumab) in combination with Yervoy (ipilimumab) for treating patients with ...

Allergan Gains Approval for Juvederm Lip Augmentation

[ Price : $8.95]

FDA approves an Allergan PMA to market Juvederm Ultra XC, a dermal filler for injection into the lips and perioral area for lip au...

Panel to Discuss Fluroquinolone Antibacterials

[ Price : $8.95]

Federal Register Notice: FDAs Antimicrobial Drugs and the Drug Safety and Risk Management Advisory Committees will discuss 11/5 sy...

Panel to Discuss Bulk Drug Substance Nominees

[ Price : $8.95]

Federal Register Notice: FDAs Pharmacy Compounding Advisory Committee will meet 10/27-28 to discuss ten bulk drug substances nomin...

Questionable Results for Priority Review Vouchers: Study

[ Price : $8.95]

Bloomberg News reports that FDA is trying to increase drug company inspections in China to ensure the quality of finished drugs an...

Cardiac Ablation Remote into Class 2

[ Price : $8.95]

Federal Register Final order: FDA classifies the steerable cardiac ablation catheter remote control system into Class 2.

Guidance on Veterinary Feed Directive Q&A

[ Price : $8.95]

Federal Register Notice: FDA releases a small entity compliance guide and guidance entitled Veterinary Feed Directive Regulation Q...

Orphan Status for Blueprint Medicine Liver Cancer Therapy

[ Price : $8.95]

FDA grants Blueprint Medicines an orphan drug designation for BLU-554 for treating hepatocellular carcinoma.