FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Latest FDA Warning Letters

[ Price : $8.95]

FDA releases its latest batch of Warning Letters that include Sage Moon Apothecary and Yuyao Yijia Daily Chemical Co.

OPDP Outlines Drug Promotion Priorities

[ Price : $8.95]

CDERs Office of Prescription Drug Promotion says its regulatory attention in 2021 will focus on promotional materials involving hi...

Tobacco Product Substantial Equivalence Rule Withdrawn

[ Price : $8.95]

Federal Register notice: FDA withdraws a 1/21-posted final rule that provided additional information on the content and format of ...

Rule on Premarket Tobacco Product Apps Withdrawn

[ Price : $8.95]

Federal Register notice: FDA withdraws a 1/21-posted final rule that outlines requirements for premarket tobacco product applicati...

AdvaMed Wants Early Engagement on Device Safety Notices

[ Price : $8.95]

The Advanced Medical Technology Association tells FDA that early stakeholder engagement is critically important when the agency is...

Merck Scraps 2 Inferior Covid Vaccine Candidates

[ Price : $8.95]

Merck discontinues developing two Covid-19 vaccine candidates, V590 and V591 based on Phase 1 data showing that the immune respons...

Theranicas Nerivio Device Cleared for Migraine

[ Price : $8.95]

FDA clears a Theranica 510(k) for its Nerivio therapeutic device for an expanded indication for acute treatment of episodic or chr...

FDA Accepts Albireo NDA for Liver Drug

[ Price : $8.95]

FDA accepts for priority review an Albireo Pharma NDA for odevixibat for treating pruritus in patients with progressive familial i...

Aurinia Lupus Nephritis Drug Approved

[ Price : $8.95]

FDA approves an Aurinia Pharmaceuticals NDA for Lupkynis (voclosporin) in combination with a background immunosuppressive therapy ...

Boston Scientific Vercise Genus Brain Stimulator OKd

[ Price : $8.95]

FDA approves a Boston Scientific PMA for its fourth-generation Vercise Genus Deep Brain Stimulation System.