FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Amazon Distributing Unapproved New Drugs: FDA

[ Price : $8.95]

FDA warns Amazon.com that its fulfillment service is distributing unapproved new drugs sold over-the-counter as mole and skin tag ...

FDA Extends Review of Reata Pharma NDA

[ Price : $8.95]

FDA extends by three months the review of a Reata Pharmaceuticals NDA for omaveloxolone to allow time to evaluate additional data ...

Allergenic Products Advisory Panel Renewed

[ Price : $8.95]

Federal Register notice: FDA renews its Allergenic Products Advisory Committee for an additional two years beyond the charter expi...

50 NDAs Not Withdrawn Due to Safety/Efficacy: FDA

[ Price : $8.95]

Federal Register notice: FDA determines that 50 listed drug products were not withdrawn for safety or effectiveness reasons.

Appeals Court Affirms Dismissal of FOIA Case

[ Price : $8.95]

The 2nd Circuit Court of Appeals says a New York federal court properly granted summary judgment to FDA and Sarepta in a Freedom o...

FDA Says Haimen Shengbang Container Recall Class 1

[ Price : $8.95]

FDA says the Haimen Shengbang Laboratory Equipment recall of unapproved viral transport media containers is Class 1.

European Data Privacy Law Affects FDA: Attorney

[ Price : $8.95]

FDA attorney Heather Messick describes agency concerns with the European Union's General Data Protection Regulation.

Attralus Gets Orphan Status for Imaging Agent

[ Price : $8.95]

FDA grants Attralus an orphan drug designation for 124 I-AT-01 iodine (evuzamitide) as a diagnostic for managing transthyretin amy...

Myfembree Wins OK for Endometriosis Pain

[ Price : $8.95]

FDA approves Myovant Sciences/Pfizers Myfembree (relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg) for managing m...

Info Collection on Device Q-Submissions

[ Price : $8.95]

Federal Register notice: FDA seeks comments on an information collection revision entitled "Q-Submissions Program for Medical Devi...