FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Stakeholders Urge Congress to Axe the Device Tax

[ Price : $8.95]

More than 140 industry and advocacy groups urge Congress to permanently repeal the medical device tax before the end of this year.

CMC Human Gene Therapy Guidance Inadequate: PhRMA

[ Price : $8.95]

Stakeholders say a draft FDA guidance on CMC information for human gene therapy needs to be clarified and reorganized.

Revised Draft Guide on Outsourcing Facility GMPs

[ Price : $8.95]

FDA posts a revised draft guidance entitled Current Good Manufacturing Practice Guidance for Human Drug Compounding Outsourcing F...

Panel to Discuss Vaginal Surgical Mesh

[ Price : $8.95]

Federal Register notice: FDA announces a 2/12 Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee me...

Debarment Over Unapproved Oncology Drugs

[ Price : $8.95]

Federal Register notice. FDA issues an order debarring physician Su-Chiao Kuo for three years from providing services in any capac...

FDA Debars Physician Who Bought Drugs from Canada

[ Price : $8.95]

Federal Register notice: FDA has issued an order debarring David J. Fishman for three years from providing services in any capacit...

AdvaMed Urges Prioritized Work on Guidances

[ Price : $8.95]

AdvaMed identifies guidance documents that FDA should prioritize in its fiscal year 2019 plan on proposed documents to be develope...

Pfizer Hospira Unit Hit with Yet Another FDA-483

[ Price : $8.95]

FDA issues Pfizers Hospira drug unit a Form FDA-483 after inspecting the firms McPherson, KS sterile drug manufacturing site.

Pfenex NDA for Forteo Me-too Copy

[ Price : $8.95]

Pfenex files a 505(b)(2) NDA for PF708, referencing Eli Lillys osteoporosis drug Forteo.

Pear App OKd to Aid Opioid Outpatient Compliance

[ Price : $8.95]

FDA clears a Pear Therapeutics 510(k) for its mobile medical application to help increase retention in an outpatient treatment pro...