FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Krystal Biotech BLA for Topical Gene Therapy

[ Price : $8.95]

Krystal Biotech files a BLA for B-Vec (beremagene geperpavec), a topical gene therapy for treating patients with dystrophic epider...

Florida Man Arrested in HIV Drug Distribution Scheme

[ Price : $8.95]

The U.S. government arrests Lazaro Hernandez of Miami, FL, for allegedly distributing over $230 million in adulterated HIV drugs.

Converted OTC Products are Not Listed Drugs: FDA

[ Price : $8.95]

Attorney Michael Shumsky explains how a previously unknown FDA administrative change can allow NDA holders to gut the 180-day excl...

Mexican Firm Refuses FDA Inspection

[ Price : $8.95]

FDA warns Mexicos Glicerinas Industriales that its drug products are adulterated because the company refused to allow an FDA inspe...

Appeals Court Upholds WV Law on Misleading Lawyer Ads

[ Price : $8.95]

Two Shook, Hardy attorneys say the 4th Circuit Court of Appeals has upheld a West Virginia law restricting ways in which plaintiff...

CBER Pilot Program for 510(k) eSubmissions

[ Price : $8.95]

Federal Register notice: CBER announces a voluntary pilot program for sponsors of CBER-regulated 510(k) submissions entitled Elect...

Guide on Power Morcellator Containment Devices

[ Price : $8.95]

Federal Register notice: FDA makes available a draft guidance entitled Non-Clinical Performance Assessment of Tissue Containment S...

FDA Panel Shoots Down Acadia Alzheimers sNDA

[ Price : $8.95]

An FDA advisory committee votes 9-3 to not recommend approval of an Acadia Pharmaceutical resubmitted sNDA for Nuplazid (pimavanse...

FDA Denies ICAN Covid Vaccine Petition

[ Price : $8.95]

FDA denies a petition from the Informed Consent Action Network asking that it not approve Covid-19 vaccines for youths ages 12-17.