FDA Related News

Medical Devices

Field Correction on Altitude-affected Balloon Pumps

Getinge begins a field correction on about 5,223 Maquet/Getinge Cardiosave intra-aortic balloon pumps due to a potential interruption or inability to ...

Medical Devices

FDA Disagrees with Breast Implant Safety Findings

FDA disputes findings published in the Annals of Surgery that suggested an increased risk of certain connective tissue conditions, such as rheumatoid ...

CTTI Releases Real-World Evidence Meeting Summary

The Clinical Trials Transformation Initiative reports on its public meeting on best practices and needed resources for advancing use of real-world evi...

Medical Devices

Heparin-Containing Device Labeling Guidance

FDA publishes a guidance with labeling and safety testing recommendations for heparin-containing medical devices and combination products.

Human Drugs

Janssen NDA for Urothelial Cancer Drug

Janssen Pharmaceutical files an NDA seeking approval of erdafitinib for treating certain patients with locally advanced or metastatic urothelial cance...

Human Drugs

California Sues Abbvie Over Illegal Kickbacks

California files a lawsut against AbbVie alleging that it gave illegal kickbacks to health care providers to prescribe Humira (adalimumab), indicated ...

Medical Devices

FDA Lifts, Then Dashes LASIK Patients Hopes

After a decade of stonewalling injured patients complaints about adverse reactions to LASIK vision-therapy laser surgeries, CDRH lifts their hopes for...

Federal Register

Docket Number Corrected on Post-approval Changes Guide

Federal Register notice: FDA corrects an incorrect docket number appearing in a 9/11 Federal Register notice entitled Post-approval Changes to Drug Su...

Human Drugs

3 Drug Product Identifier Guidances

FDA issues one draft and two final guidances explaining provisions of the Drug Supply Chain Security Act relating to drug product identifiers.

FDA General

DoJ Argues Against APA Rules Challenges

Attorney Anne Walsh says the Justice Department has directed its civil litigators to oppose court attempts to impose nationwide injections, including ...