FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

New Models Needed to Shore Up Declining R&D, Researcher Says

[ Price : $8.95]

Washington Universitys (St. Louis) new associate vice chancellor and director of its new Center for Research Innovation in Busines...

Glaxo Reports Positive Results from Melanoma Drug Trial

[ Price : $8.95]

GlaxoSmithKline reports positive results from a planned analysis of its Phase 3 BREAK-3 study involving Tafinlar (dabrafenib) in 2...

FDA Inspected Fewer Device Firms Last Year

[ Price : $8.95]

An FDA medical device inspection report finds that the agency conducted 3% fewer medical device quality system surveillance inspec...

FDA Approves Alimera Sciences NDA for Illuvien

[ Price : $8.95]

FDA approves an Alimera Sciences NDA for Iluvien for treating diabetic macular edema in patients who have been previously treated ...

FDA Accepts BMS Submission for Melanoma Therapy

[ Price : $8.95]

FDA accepts for priority review a Bristol-Myers Squibb BLA for Opdivo (nivolumab), an investigational PD-1 immune checkpoint inhib...

Guidance on Evidence of Grandfathered Tobacco Products

[ Price : $8.95]

Federal Register Notice: FDA releases a guidance: Establishing That a Tobacco Product Was Commercially Marketed in the United Stat...

Appeals Court Rules Against FDA in 510(k) Rescission Case

[ Price : $8.95]

A federal appeals court deals FDA a blow, ruling that it cannot short-circuit the statutory medical device reclassification proces...

Comments Sought on Animal Drug AERs

[ Price : $8.95]

Federal Register Notice: FDA seeks comments on new animal drug adverse event reporting.

Comments Extended on Social Media Risk/Benefit Guidance

[ Price : $8.95]

Federal Register Notice: FDA reopens the comment period for a draft guidance on Internet/Social Media Platforms with Character Spa...

Comments Extended on Internet/Social Media Corrections Guidance

[ Price : $8.95]

Federal Register Notice: FDA reopens the comment period on a draft guidance on correcting third party misinformation about drugs/d...