FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

New CDISC Versions Support and Use Dates Announced

[ Price : $8.95]

Federal Register notice: FDA announces the date that support begins for versions 1.2 and 1.3 of the Clinical Data Interchange Stan...

Acadia Pharmaceuticals NDA for Rett Syndrome

[ Price : $8.95]

Acadia Pharmaceuticals files an NDA for trofinetide for treating Rett syndrome in adults and pediatric patients two years of age a...

Lawmakers Push FDA for ALS Therapies

[ Price : $8.95]

A group of bipartisan lawmakers write FDA asking that it do more to help get therapies approved for treating amyotrophic lateral s...

FDA Reform Needed to Address Lack of Urgency: Forbes

[ Price : $8.95]

Pacific Research Institute president Sally Pipes says FDAs foot dragging in recommending updated Covid-19 vaccines last month and ...

FDA Revoking Methods of Analysis Regulation

[ Price : $8.95]

Federal Register proposed rule: FDA proposes to revoke its methods of analysis regulation (21 CFR 2.19) that describes policy to u...

FDA Revokes EUA on Covid Detection Kit

[ Price : $8.95]

Federal Register notice: FDA revokes the emergency use authorization issued to ScienCell Research Laboratories for its ScienCell S...

Guide on Instructions for Use Patient Labeling

[ Price : $8.95]

Federal Register notice: FDA makes available a final guidance entitled Instructions for UsePatient Labeling for Human Prescription...

Provepharm NDA for Bludigo Approved

[ Price : $8.95]

FDA approves a Provepharm NDA for Bludigo (indigotindisulfonate sodium), a diagnostic dye indicated for use as a visualization aid...

Senator Burr Introduces 'Clean' Version of User Fee Bill

[ Price : $8.95]

Senator Richard Burr (R-NC) introduces a "watered-down" and less controversial FDA user fee reauthorization bill that is intended ...

Pfizers Xalkori OKd for Myofibroblastic Tumors

[ Price : $8.95]

FDA approves a Pfizer supplemental NDA for Xalkori (crizotinib) for adult and pediatric patients with unresectable, recurrent, or ...