FDA Related News

In Vitro Diagnostic Submission Streamlined Guidance

FDA issues a guidance on a streamlined submission process for oncology investigational IVDs.

Medical Devices

FDA Software Guidance Discussed

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

Medical Devices

Beckman Coulter Lab Automation Device Cleared

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

Federal Register

Workshop on Pediatric Clinical Trial Endpoints

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

Federal Register

Priority Voucher Awarded to Bavarian Nordic

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

Medical Devices

Death Misclassifications in MAUDE Database

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

FDA General

FDA Working with CBP to Identify Illicit Vaping Products

FDA acting commissioner Ned Sharpless says the agency is working with Customs and Border Protection to identify potentially illicit vaping products co...

Medical Devices

Medtronic Breakthrough with Aortic Aneurysm Stent

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

Human Drugs

Octapharmas Wilate Expanded Use in Adults/Adolescents

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

Human Drugs

FDA Denies Olmesartan Withdrawal Petition

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