FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Panel to Review Peanut Allergy Therapy

[ Price : $8.95]

Federal Register notice: FDA announces a 5/15 Allergenic Products Advisory Committee meeting to review DBV Technologies Peanut (Ar...

FDA Officials Discuss Real-world Data/Evidence

[ Price : $8.95]

Two senior CDER officials discuss how real world data and real world evidence can be used in making regulatory decisions, and desc...

Taro Pharma Recalls Phenytoin Oral Suspension

[ Price : $8.95]

Taro Pharmaceuticals recalls two lots of phenytoin oral suspension USP, 125 mg/5 mL in 237 mL bottles because it may not re-suspen...

Asuragen De Novo Granted for Fragile X Test

[ Price : $8.95]

FDA grants de novo marketing authorization to Asuragens AmplideX Fragile X Dx and Carrier Screen Kit for detecting Fragile X Syndr...

GSK sNDA for Zejula as Ovarian Cancer Maintenance

[ Price : $8.95]

FDA accepts for review a GlaxoSmithKline supplemental NDA for Zejula (niraparib) as a first-line maintenance treatment for women w...

Avanos Medical New RF Pain Device Cleared

[ Price : $8.95]

FDA clears an Avanos Medical 510(k) for its new, 80-Watt Coolief Radiofrequency system for pain-reducing neurological lesion proce...

Teva sNDA Approved for ArmonAir Digihaler

[ Price : $8.95]

FDA approves a Teva Respiratory supplemental NDA for ArmonAir Digihaler (fluticasone propionate) Inhalation Powder, an inhaled cor...

Info Collection for Device Corrections/Removals

[ Price : $8.95]

Federal Register notice: FDA seeks comments on an information collection extension for Medical Devices; Reports of Corrections and...

Final Rule Defines Biological Product

[ Price : $8.95]

Federal Register final rule: FDA issues a final rule to amend its regulation that defines biological product to incorporate change...

FDA Reclassifying Certain HIV Tests

[ Price : $8.95]

Federal Register proposed order. FDA proposed to reclassify certain human immunodeficiency virus (HIV) serological diagnostic and ...