FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Orphan Status for Diffusion Pharma Brain Cancer Therapy

[ Price : $8.95]

FDA grants Diffusion Pharmaceuticals an Orphan Drug designation for trans sodium crocetinate and its use in treating metastatic br...

Multiple QS Violations Found at Parks Medical Electronics

[ Price : $8.95]

FDAs Seattle District Office warns Parks Medical Electronics about multiple Quality System violations at its facility manufacturin...

Drug Sponsors Shun Biosimilars Pathway: FDA

[ Price : $8.95]

CDER associate director for biosimilars Leah Christl says biosimilar product developers have essentially ignored FDAs abbreviated ...

Roxane Wants Jazz Xyrem Petition Denied

[ Price : $8.95]

Roxane tells FDA it should deny Jazz Pharmaceuticals latest citizen petition seeking to delay review of any ANDAs for generic Xyre...

Senators Want Medical Device Tax Delayed

[ Price : $8.95]

AdvaMed praises a call by 18 senators for a delay in implementation of the upcoming medical device tax.

FDA Denies Merck Nasonex Petition

[ Price : $8.95]

FDA denies a Merck petition asking that it not accept ANDAs for generic Nasonex.

FDA 6-month Pediatric Exclusivity for Aciphex

[ Price : $8.95]

FDA awards Eisai an additional six months marketing exclusivity for Aciphex for meeting criteria under the agencys pediatric exclu...

MDR, QS Violations Found at MedArt

[ Price : $8.95]

FDA warns MedArt about Medical Device Reporting and Quality System violations found in an inspection at a company manufacturing fa...

FDA Clears Lensar Laser for Corneal Incisions

[ Price : $8.95]

FDA clears a Lensar 510(k) for its laser system for use in executing corneal incisions during cataract surgery.

CDER First-Cycle Approvals Highest in 20 Years: Jenkins

[ Price : $8.95]

CDER Office of New Drugs director John Jenkins says the first-cycle approval rate in 2012 is at the highest level in 20 years.