Opinion for the Court filed by Circuit Judge SENTELLE.
SENTELLE, Circuit Judge.
A number of advocacy organizations and individuals seek review of regulatory inaction by the Food and Drug Administration ("FDA"). They assert that the FDA should classify, under the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §§ 301-399 ("FDCA" or the "Act"), a material commonly used for dental fillings. The material, they contend, must be regulated by the FDA in...
Let's get started
Welcome to the leading source of independent legal reporting
Sign on now to see your case.
Or view more than 10 million decisions and orders.
- Updated daily.
- Uncompromising quality.
- Complete, Accurate, Current.