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Disclosure Requirements › Federal Food Drug and Cosmetic Act (FFDCA) › Regulatory Requirements

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

Goodwin

FDA’s Push for “Radical Transparency”: Key Takeaways from the Agency’s Publication of Complete Response Letters

Goodwin on

On July 10, 2025, the U.S. Food and Drug Administration (FDA) announced publication of over 200 complete response letters (CRLs) issued in response to applications submitted to FDA for approval of drugs or biologics between...more

King & Spalding

USDA Publishes Long-Awaited Final Rule on the Labeling of “Bioengineered” Food

King & Spalding on

On December 21, 2018, the Agricultural Marketing Service (AMS) of the U.S. Department of Agriculture (USDA) issued a final rule1 (BE Final Rule) to implement the National Bioengineered Food Disclosure Standard (NBFDS),2 which...more

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