FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Safety Alert on Abbotts MitraClip Delivery Systems

[ Price : $8.95]

FDA issues a safety alert to warn about potential clip lock malfunctions with Abbotts MitraClip Delivery Systems.

FDA Approves Daxxify for Frown Lines

[ Price : $8.95]

FDA approves a Revance Therapeutics BLA for injectable Daxxify (daxibotulinumtoxinA-lanm) for temporarily improving moderate-to-se...

Nonprescription Drug Label Guidance

[ Price : $8.95]

FDA issues a draft guidance intended to improve the consistency of labeling for nonprescription drugs.

2nd Time a Charm in ALS Drug Panel Vote

[ Price : $8.95]

In an unusual second advisory committee meeting in six months, panel members reverse their March vote and recommend approval for A...

7 Observations in Koreas Hugel FDA-483

[ Price : $8.95]

FDA releases a Form FDA-483 with seven observations from an inspection at Koreas Hugel drug substance and drug product manufacturi...

Pharmacology Pediatric Studies Guidance

[ Price : $8.95]

FDA publishes a draft guidance on general clinical pharmacology considerations for pediatric studies of drugs, including biologics...

Philips Respironics Recalls 17 Million Airway Masks

[ Price : $8.95]

Philips Respironics recalls 17 million masks used with bilevel positive airway pressure machines and continuous positive airway pr...

Panel to Discuss EUA for Covid-19 Therapy

[ Price : $8.95]

Federal Register notice: FDA announces a 10/6 advisory committee meeting to discuss a Veru Inc. request for an emergency use autho...

Priority Voucher Used on Genentechs Vabysmo Approval

[ Price : $8.95]

Federal Register notice: FDA announces that a product was approved using a priority review voucher Genentechs Vabysmo (faricimab-...

CDER, CBER Accept 1st ISTAND Submission

[ Price : $8.95]

CDER and CBER accept the first letter of intent submission for the new Innovative Science and Technology Approaches for New Drugs ...