FDA Related News

Human Drugs

Comments on Inactive Ingredient Database Guidance

Four stakeholders comment on an FDA draft guidance on its inactive ingredient database.

Medical Devices

UTC Laboratories Settles FCA Charges for $42.6 Million

The Justice Department says UTC Laboratories and its three principals will pay $42.6 million to resolve six whistleblower False Claims Act suits.

Medical Devices

ICU Recalls Infusion Sets Over Leak Issue

ICU Medical recalls certain lots of Plum and Sapphire Microbore Infusion Sets with inline filters due to the potential for fluid leaks.

Human Drugs

Challenges of N-of-one Medicine: Woodcock, Marks

FDAs CDER and CBER directors look at the many regulatory, ethical, and societal issues raised by developing drugs to treat a single individual through...

Medical Devices

2 Final Coronary Guidances Out

FDA releases final guidances on device labeling for intravascular catheters and other devices and on guidewire performance tests and labeling.

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...