FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

FDA Panel Backs Daiichi Sankyo Stroke Drug

[ Price : $8.95]

FDAs Cardiovascular and Renal Drugs Advisory Committee recommends approval of Daiichi Sankyos once-daily Savaysa (edoxaban) 60 mg ...

Revive Plans Trial for Bucillamine in Gout Patients

[ Price : $8.95]

Revive Therapeutics files an IND to FDA for REV-002 (bucillamine) for treating gout.

Info on Commissioners Fellowship Program Sent to OMB

[ Price : $8.95]

Federal Register Notice: FDA submits a proposed collection of information to the Office of Management and Budget on the FDA commis...

FDA Corrects Notice on Recordkeeping for Exports

[ Price : $8.95]

Federal Register Notice: FDA corrects a notice on exports and notification and recordkeeping requirements.

Several Drug Products Not Withdrawn for S&E

[ Price : $8.95]

Federal Register Notice: FDA determines that several drug products were not withdrawn from sale for reasons of safety or effective...

FDA OKs TWi Pharmas Generic Aricept

[ Price : $8.95]

FDA grants final approval to TWi Pharmaceuticals for its ANDA for a generic version of Eisais Aricept, 23 mg to treat Alzheimers d...

Amgen Asks for Biosimilar Submission Alerts to Innovators

[ Price : $8.95]

Amgen petitions FDA to require biosimilar applications to include a certification by the applicant that they will provide the refe...

Takeda Court Filing Questions FDAs Mitigare Approval

[ Price : $8.95]

A Takeda court filing says FDAs approval of Hikma Pharmaceuticals 505(b)(2) application last month for Mitigare (colchicine) was a...

Participants Sought to Select Tobacco Panel Reps

[ Price : $8.95]

Federal Register Notice: FDA is requesting participants to help select nonvoting industry representatives for the Tobacco Products...

First Custom Design Exemption Report Due in March

[ Price : $8.95]

A CDRH Webinar on a recent custom design exemption guidance confirmed that the first annual report mandated by the guidance is due...