Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more
In the last month, the Food and Drug Administration has suffered setbacks relating to off-label promotion oversight. In both cases, one involving a pharmaceutical company and the other a medical device firm and its Chief...more
Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more
To quote the late Yogi Berra, it must feel like déjà vu all over again for the Food and Drug Administration (FDA) (or, if you prefer, Crosby, Stills, Nash & Young’s song, “Déjà Vu” (“We have all been here before”)). Fresh off...more
9/22/2015
/ Administrative Procedure Act ,
Amarin ,
Declaratory Relief ,
Due Process ,
Enforcement Actions ,
Ex Post Facto Clause ,
Fair Notice ,
FDA Warning Letters ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Fifth Amendment ,
First Amendment ,
Food and Drug Administration (FDA) ,
Free Speech ,
Injunctive Relief ,
Misbranding ,
Off-Label Promotion ,
Off-Label Use ,
Pharmaceutical Industry
In the most recent court decision, Amarin Pharma, Inc. v. United States Food and Drug Administration, No. 15 Civ. 3588 (PAE) (S.D. N.Y. August 5, 2015), a U.S. District Court granted Amarin's preliminary injunction to...more