FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Clinical Hold on 3 CARsgen CAR T-cell Therapies

[ Price : $8.95]

FDA places a clinical hold on three CARsgen Therapeutics clinical trials due to chemistry, manufacturing and controls questions ra...

Stakeholder Technical Issues with Ophthalmic Guide

[ Price : $8.95]

Four stakeholders submit specific technical concerns about an FDA draft guidance on topical ophthalmic drug quality considerations...

FDA Approves Neuroblastoma Drug

[ Price : $8.95]

FDA approves a U.S. WorldMeds NDA for eflornithine for reducing the risk of relapse in certain adult and pediatric patients with h...

Update GAO Device Recall Oversight Report: Senators

[ Price : $8.95]

Sens. Durbin and Blumenthal ask the Government Accountability Office to update its 2011 report on FDA oversight of medical device ...

Novid Distributing Unapproved, Misbranded Drug: FDA

[ Price : $8.95]

FDA warns Northridge, CA-based Novid Group that it is illegally distributing an unapproved and misbranded over-the-counter antihis...

Vertex Moving Neuropathy Pain Drug to Phase 3

[ Price : $8.95]

Vertex Pharmaceuticals says it will advance selective NaV1.8 inhibitor VX-548 into pivotal Phase 3 studies based on positive resul...

Guide on Advanced Manufacturing Tech

[ Price : $8.95]

Federal Register notice: FDA makes available a draft guidance entitled Advanced Manufacturing Technologies Designation Program.

Genetic Metabolic Disease Panel Established

[ Price : $8.95]

Federal Register notice: FDA creates the Genetic Metabolic Diseases Advisory Committee to review and make recommendations on inves...

Regulatory Affairs, Foods Program Under Review

[ Price : $8.95]

FDA says HHS has started reviewing the agencys proposed reorganization for a unified Human Foods Program and a revised Office of R...

HELP Committee OKs EFFECTIVE Opioid Bill

[ Price : $8.95]

The Senate HELP Committee passes legislation giving FDA additional authority to deny opioid analgesic NDAs.