FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

FDA OKs Alpharma sANADA for Bacterial Diseases

[ Price : $8.95]

Federal Register Final rule: FDA approves an Alpharma ANADA for using generic chlortetracycline soluble powder to make medicated d...

Correction on Pediatric Panel Notice

[ Price : $8.95]

Federal Register Notice: FDA corrects a docket number in an 11/2 notice on a Pediatric Advisory Committee meeting.

Latest FDA Warning Letters

[ Price : $8.95]

In its latest batch of Warning Letters, FDA cites Centra Support Building, King Systems, TLC Eye Care-Lansing, and Wellspring Inte...

FDA Clears Masimo Respiration Rate Monitor

[ Price : $8.95]

FDA clears a Masimo 510(k) for the Masimo Rainbow SET Acoustic Monitoring system for monitoring continuous respiration rate in pos...

FDA Raises Numerous Issues on Ampligen NDA

[ Price : $8.95]

FDA calls for an additional clinical trial to support Hemispherx Biopharmas Ampligen NDA.

Teva Files BLA for Neupogen Biosimilar

[ Price : $8.95]

Teva submits a BLA for XM02, a granulocyte colony-stimulating factor (G-CSF) indicated for reducing the duration of severe neutrop...

FDA Makes Product-Specific BE Recommendations

[ Price : $8.95]

Federal Register Notice: FDA releases additional draft and revised draft product-specific bioequivalence recommendation.

Guidance on Modified Risk Tobacco Products

[ Price : $8.95]

Federal Register Notice: FDA releases a draft guidance on a preliminary timetable for FDAs review of applications for modified ris...

Panel to Discuss Forest sNDA for Chronic Heart Failure

[ Price : $8.95]

Federal Register Notice: FDAs Cardiovascular and Renal Drugs Advisory Committee will meet 1/11/10 to discuss a Forest Labs sNDA fo...

Tobacco Ingredients Guidance Out

[ Price : $8.95]

Federal Register Notice: FDA releases a guidance on the listing of ingredients in tobacco products.