FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

What Does 510(k) Clearance Show at Trial on Safety?

[ Price : $8.95]

Attorney John Sullivan questions a courts decision to allow trial testimony on a Boston Scientific 510(k) clearance, but with a ve...

FDA Concerns About Chinese Drugs Detailed

[ Price : $8.95]

Bloomberg News reports that FDA is trying to increase drug company inspections in China to ensure the quality of finished drugs an...

FDA Extends NDA Review for Newrons Parkinsons Drug

[ Price : $8.95]

FDA extends by three months its review of a Newron Pharmaceuticals NDA for Xadago (safinamide), indicated as add-on therapy in bot...

FDA Seeks Participants for Biosimilar Act Reauthorization

[ Price : $8.95]

Federal Register Notice: FDA request that drug companies and trade associations notify the agency of an intent to participate in t...

Medtronic PMA Approved for Bladder/Bowel Evaluations

[ Price : $8.95]

FDA approves a Medtronic PMA for the Verify Evaluation System for use in making basic bladder/bowel evaluations, which last up to ...

FDA Social Media Rules Violate 1st Amendment: WLF

[ Price : $8.95]

Washington Legal Foundation says FDA should consider that a successful First Amendment challenge is likely against its social medi...

Pew Warns Against Expanding Animal Antibiotic OKs

[ Price : $8.95]

The Pew Charitable Trusts says FDA should not expand conditional approvals for antibiotics beyond minor species or minor uses in m...

QS, MDR Violations Found in Ultroid Inspection

[ Price : $8.95]

FDAs Florida District Office warns Ultroid Technologies about QS and MDR violations in its manufacturing of a misbranded hemorrhoi...

Microport Ortho Recall Profemur Hip Prosthesis

[ Price : $8.95]

MicroPort Orthopedics begins a Class 1 recall of the Profemur Plus Cocr Modular Neck orthopedic hip prosthesis component due to an...

Tighten Animal Drug Compounding Oversight: GAO

[ Price : $8.95]

A new Government Accountability Office report recommends that FDA improve its oversight of drug compounding for animal use.