FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

FDA Software Guidance Discussed

[ Price : $8.95]

Attorney Michelle Bufano discusses elements of the recent FDA guidance on medical software and apps.

Beckman Coulter Lab Automation Device Cleared

[ Price : $8.95]

FDA clears a Beckman Coulter 510(k) for the DxA 5000 total laboratory automation system.

Workshop on Pediatric Clinical Trial Endpoints

[ Price : $8.95]

Federal Register notice: FDA announces an 11/12 public workshop on patient perspectives in pediatric clinical trial endpoints for ...

Priority Voucher Awarded to Bavarian Nordic

[ Price : $8.95]

Federal Register notice: FDA announces that it has issued a material threat medical countermeasure priority review voucher to Bava...

Death Misclassifications in MAUDE Database

[ Price : $8.95]

Researchers say they found substantial misclassification of patient deaths in the FDA MAUDE medical device database.

FDA Working with CBP to Identify Illicit Vaping Products

[ Price : $8.95]

FDA acting commissioner Ned Sharpless says the agency is working with Customs and Border Protection to identify potentially illici...

Medtronic Breakthrough with Aortic Aneurysm Stent

[ Price : $8.95]

FDA grants Medtronic a breakthrough device designation for its Valiant TAAA Stent Graft System for repairing thoracoabdominal aort...

Octapharmas Wilate Expanded Use in Adults/Adolescents

[ Price : $8.95]

FDA approves Octapharmas Wilate (von Willebrand factor/coagulation factor VIII complex) for treating adults and adolescents with h...

FDA Denies Olmesartan Withdrawal Petition

[ Price : $8.95]

FDA denies a Public Citizen petition seeking removal of products containing olmesartan medoxomil from the market for safety reason...

FDA Hits Troubled Aurobindo with Form-483

[ Price : $8.95]

FDA issues Aurobindo a Form-483 after an inspection last month at the firms Unit 7 manufacturing facility in Telangana, India.