News & Analysis as of

Medical Devices › Regulatory Agencies › Federal Food Drug and Cosmetic Act (FFDCA)

Ropes & Gray LLP

FDA Commissioner Makary Promises “Real Time” Release of Complete Response Letters: Can FDA Really Do That?

Ropes & Gray LLP on

On July 10, 2025, in the name of embracing “radical transparency,” the U.S. Food and Drug Administration (“FDA”) announced that it was publishing more than 200 complete response letters (“CRLs”) issued in response to drug and...more

King & Spalding

FDA's LDT Rule Struck Down by Court: FDA Has Lost the Battle, But Is the War Over?

King & Spalding on

A court has struck down the Food and Drug Administration’s attempt to extend its regulatory authority to clinical laboratory testing services. On March 31, 2025, in the consolidated cases American Clinical Laboratory...more

2 Results
 / 
View per page
Page: of 1

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
Sign up Log in
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide