FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

FDA Posts FDA-483s from 2 Indian Companies

[ Price : $8.95]

FDA releases the forms FDA-483 with multiple observations from inspections at Granules India Limited and Gland Pharma, both drug m...

Firms Seek Broad Extrapolation for Pediatric IBD Dosing

[ Price : $8.95]

Joint comments from three major drug companies about pediatric inflammatory bowel disease drug development question why FDA does n...

Rubio, King Push FDA on Advanced Drug Manufacturing

[ Price : $8.95]

Sens. Rubio and King push FDA to quickly finish implementing the Advanced Manufacturing Technologies Designation Program so indust...

ICER Questions Diversity Action Plan Goal

[ Price : $8.95]

The Institute for Clinical and Economic Review asks FDA to reconsider the implications of its stated goal in a draft guidance on c...

FDA OKs Keytruda Pleural Mesothelioma Indication

[ Price : $8.95]

FDA approves an additional indication for Mercks Keytruda with chemotherapy to treat unresectable advanced or metastatic malignant...

Bill Introduced on Generic Drug Prompt Approvals

[ Price : $8.95]

Congresswoman Nanette Barragn (D-CA) reintroduces the Prompt Approval of Safe Generic Drugs Act, legislation that would remove hur...

FDA Review of Govorestat on Track: Company

[ Price : $8.95]

FDA tells Applied Therapeutics its govorestat is on track for the 11/28 PDUFA action date and will not need to go before an adviso...

Smiths Medical Recalls Bivona Tracheostomy Tubes

[ Price : $8.95]

Smiths Medical recalls (Class 1) several lots of its Bivona Neonatal/Pediatric and Adult Tracheostomy tubes due to a manufacturing...

Fasenra OKd for Rare Vasculitis

[ Price : $8.95]

FDA approves AstraZenecas Fasenra (benralizumab) for treating adult patients with eosinophilic granulomatosis with polyangiitis.

Integrating Trials into Clinical Practice Guide

[ Price : $8.95]

Federal Register notice: FDA makes available a draft guidance entitled Integrating Randomized Controlled Trials for Drug and Biolo...