FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Pilot on CDISC Non-Clinical Study Data eSubmission

[ Price : $8.95]

Federal Register notice: FDA announces a pilot program to test the processing and analysis of nonclinical study data provided elec...

NDA Withdrawal Notice from 2011 Corrected

[ Price : $8.95]

Federal Register notice: FDA corrects a 6/8/2011 notice about the approval withdrawal of 70 NDAs and 97 ANDAs from multiple applic...

Workshop on FDAs Predictive Toxicology Roadmap

[ Price : $8.95]

Federal Register notice: FDA plans workshop to provide an update on its predictive toxicology roadmap.

USP Wants Reporting Threshold Comments

[ Price : $8.95]

The United States Pharmacopeia sets a 90-day comment period for a proposed policy change relating to publication of reporting thre...

Sarepta Golodirsen Complete Response Letter

[ Price : $8.95]

Sarepta wants to schedule a meeting with FDA to discuss next steps following a complete response letter for its Duchenne muscular ...

Advisors Look at Pediatric OxyContin Safety Review

[ Price : $8.95]

The FDA Pediatric Advisory Committee and Risk Management Advisory Committee schedule a joint meeting 9/26-27 to look at pediatric ...

Turner Scientific Wants Its Ototoxicity Draft Guidance Issued

[ Price : $8.95]

Turner Scientific asks FDA to adopt and issue a guidance the company drafted on routine testing of drugs and biologics for ototoxi...

Brain Stimulator Gets MRI-use Labeling Approved

[ Price : $8.95]

FDA approves a Boston Scientific PMA supplement for its ImageReady MRI labeling for the Vercise Gevia Deep Brain Stimulation Syste...

Dr. Reddys Hit with Another FDA-483

[ Price : $8.95]

FDA sends Dr. Reddys Laboratories an eight-observation Form FDA-483, the third inspection form in six weeks for one of its facilit...

Latest FDA Warning Letters

[ Price : $8.95]

FDA releases its latest batch of Warning Letters that includes Deva Holding, Polymer Technology Systems and TG United.