Regulatory Oversight, Food and Drug Administration (FDA), Appeals

District Court Vacates FDA LDT Rule; What’s Next for Regulation of Lab Testing?

Akin Gump Strauss Hauer & Feld LLP on 4/4/2025

On March 31, 2025, Judge Sean D. Jordan of the U.S. District Court for the Eastern District of Texas issued an opinion and judgment in American Clinical Laboratory Association v. FDA. Judge Jordan’s decision vacates and sets...more

Ninth Circuit Rules on Legality of Delta-8 THC Products

Perkins Coie on 5/20/2022

On May 19, 2022, the U.S. Circuit Court of Appeals for the Ninth Circuit issued an opinion holding that Delta-8 THC products are legal at the federal level and eligible for intellectual property protection...more

Food and Beverage Law Update: December 2018

Holland & Knight LLP on 12/24/2018

Regulation - FDA-USDA Propose Joint Regulatory Framework for Cell-Grown Meat - On Nov. 16, 2018, the U.S. Food and Drug Administration (FDA) and the U.S. Department of Agriculture (USDA) issued a joint statement...more

Food & Beverage Litigation Update | June 2018 #2

Shook, Hardy & Bacon L.L.P. on 6/18/2018

LEGISLATION, REGULATIONS & STANDARDS - FDA Releases Guidance on Dietary Fiber Labeling - The U.S. Food and Drug Administration has released guidance identifying eight non-digestible carbohydrates that the agency intends...more

FDA proposes streamlining combination product regulations

Hogan Lovells on 5/31/2018

On May 15, 2018, the Food and Drug Administration (FDA) proposed amending its product classification rules for combination products, found in 21 CFR Part 3. Generally, the proposed rule purports to clarify language in the...more

A "cure" for combination products: 21st Century Cures Act mandates greater transparency of combination product designations

Hogan Lovells on 1/25/2017

The 21st Century Cures Act ushers in significant changes to the regulatory review of drug/biologic/device combination products. The regulation of combination products has been somewhat unpredictable and muddled over the last...more