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Regulatory Requirements › Food and Drug Administration (FDA) › Regulatory Agencies

Troutman Pepper Locke

FDA Sued Over Years-Long Internal Review of Flavored ENDS MDO

Troutman Pepper Locke on

On August 21, 2025, NJOY, LLC (NJOY), a subsidiary of Altria Group, Inc., sued the U.S. Food and Drug Administration (FDA), alleging that the agency has unlawfully delayed rendering a decision on supervisory review of its...more

Bradley Arant Boult Cummings LLP

Crank the Party Up: Is the DEA About to Get It On with Psilocybin?

Bradley Arant Boult Cummings LLP on

On August 11, 2025, the U.S. Drug Enforcement Administration officially transmitted a request to the Department of Health and Human Services to loosen the federal restriction on psilocybin, seeking to move one of the...more

ArentFox Schiff

FDA and USDA Seek Public Input to Help Define ‘Ultra-Processed Foods’ as Part of MAHA Campaign

ArentFox Schiff on

On July 23, the US Food and Drug Administration (FDA) and US Department of Agriculture (USDA) announced a coordinated initiative to address health risks associated with so-called “ultra-processed foods.”...more

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

Mintz - Health Care Viewpoints

Health Law Diagnosed – Best Practices for Communicating with the FDA

Mintz - Health Care Viewpoints on

In the latest episode of Health Law Diagnosed , Of Counsel Bridgette Keller hosts a discussion of best practices for interacting and communicating with the FDA....more

American Conference Institute (ACI)

[Virtual Conference] Food Law and Regulation Boot Camp - July 22nd - 23rd, 8:15 am - 2:00 pm CST

American Conference Institute (ACI) on

Food laws and regulations are evolving rapidly — you and your team must prepare now to navigate the changes and anticipate what’s next on the horizon. ACI's virtual Food Law and Regulation Boot Camp will equip you with the...more

Mintz - ML Strategies

What You Need to Know: State and Federal Updates Related to COVID-19

Mintz - ML Strategies on

...On Monday, House Speaker Nancy Pelosi, Majority Whip James Clyburn, Transportation & Infrastructure Committee Chairman Peter DeFazio, and Energy & Commerce Committee Chairman Frank Pallone held a press conference on a...more

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