FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

FDA Denies Celgene Thalidomide ANDA Petition

[ Price : $8.95]

FDA denies a 2007 Celgene petition asking it not to approve any ANDAs for generic Thalomid.

Pharma Loses in California Drug Disposal Case

[ Price : $8.95]

The U.S. Court of Appeals for the Ninth Circuit rules that efforts by Alameda County, CA to collect disposal costs from drug compa...

Avedro Refiles NDA for Ophthalmic Therapy

[ Price : $8.95]

Avedro resubmits an NDA for the KXL System (riboflavin ophthalmic solution), indicated for treating progressive keratoconus or cor...

Hamburg Defends Zohydro Actions

[ Price : $8.95]

FDA commissioner Margaret Hamburg defends the agencys handling of Zohydro, as USA Today urges that the approval be reconsidered.

Studies Query Data for 510(k) OKs, Post Approval Studies

[ Price : $8.95]

Researchers say FDA needs to do a better job making sure scientific evidence to support 510(k) clearances is publicly available, w...

CDER OKs Reminder-like Posts for Boxed Warning Drugs

[ Price : $8.95]

CDER Office of Prescription Drug Promotion special assistant to the director Jean-Ah Kang says firms can use reminder-like promoti...

FDA Awards $19 Million in Rare Disease Product Develoment Grants

[ Price : $8.95]

FDA awards 15 grants totaling more than $19 million to stimulate drug, medical device, and biological product development for pati...

Latest FDA Warning Letters

[ Price : $8.95]

In its latest batch of Warning Letters, FDA cites ArjoHuntleigh, CalComp Nutrition, dōTERRA International, Express Diagnostic...

Discussion Paper on Brain-Computer Interface Devices

[ Price : $8.95]

FDA releases a discussion paper in preparation for its Brain-Computer Interface (BCI) Devices for Patients with Paralysis and Ampu...

Express Diagnostics Inspection Yields QS Issues

[ Price : $8.95]

FDAs Minneapolis District Office warns Express Diagnostics International about Quality System problems in its production of drug o...