FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Janssen Multiple Myeloma Drug Given Accelerated Approval

[ Price : $8.95]

FDA grants accelerated approval to a Janssen Biotech NDA for Darzalex (daratumumab) for treating patients with multiple myeloma wh...

Should FDA Move to European Model for Approving Devices/Drugs?

[ Price : $8.95]

An opinion piece by a former FDA official in the Charleston Gazette-Mail says the U.S. would be better served if it moved more tow...

CDER Reports Problems with Clozapine REMS Program

[ Price : $8.95]

CDER says it is receiving reports from healthcare professionals about ongoing difficulties with the Clozapine REMS Program, includ...

FDA Guidance on Acetaminophen Liver Warning Labeling

[ Price : $8.95]

FDA posts a guidance on Organ-Specific Warnings: Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Cou...

Draft Guidance on IVDs for Bacillus spp. Detection

[ Price : $8.95]

FDA releases a draft guidance on Class II Special Controls Guideline: In Vitro Diagnostic Devices for Bacillus spp. Detection.

Alliance for Stronger FDA Urges Budget Letter Campaign

[ Price : $8.95]

The Alliance for a Stronger FDA urges a letter writing campaign from its members to prod Capitol Hill appropriators to increase th...

FDA Clears Spectranetics Laser Atherectomy Catheter

[ Price : $8.95]

FDA clears a Spectranetics 510(k) for its Turbo-Power Laser Atherectomy Catheter and its use in treating in-stent restenosis.

Comments Sought on Harmful Tobacco Constituent Info

[ Price : $8.95]

Federal Register Notice: FDA seeks comments on a collection of information on the reporting of harmful constituents in tobacco pro...

PhRMA, GPhA Differ on FDA Naming Convention for Biosimilars

[ Price : $8.95]

Pharmaceutical Research and Manufacturers of America says it supports FDAs proposed naming policy that calls for biological produc...

Guidance on Biomarkers in Treatments of Aspergillosis

[ Price : $8.95]

Federal Register Notice: FDA is making available a guidance for industry entitled Guidance on Qualification of Biomarker Galactom...