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Administrative Procedure Act Federal Food Drug and Cosmetic Act (FFDCA)

Venable LLP

Implications of Loper Bright for FDA-Regulated Products

Venable LLP on

Recently, Venable's Government Division offered its general thoughts on the fallout from the Supreme Court's reversal of the long-standing Chevron deference principle. Here, the FDA Practice Group offers some of its own...more

McDermott Will & Emery

Loper Bright Could Shift Outlook for FDA Legal Challenges

The US Supreme Court has overruled the longstanding Chevron doctrine, an administrative law doctrine that required courts to defer to reasonable agency interpretations of ambiguous statutes. Loper Bright Enterprises v....more

Goodwin

Lawsuit Filed Challenging FDA Final Rule Regulating Laboratory Developed Tests

Goodwin on

On May 29, 2024, a lawsuit was filed in the U.S. District Court for the Eastern District of Texas, challenging the U.S. Food and Drug Administration’s final rule concerning the regulatory status of laboratory developed tests...more

Hogan Lovells

Federal Court Sides with FDA and Upholds GRAS Rule

Hogan Lovells on

The U.S. District Court for the Southern District of New York granted the U.S. Food and Drug Administration’s (FDA or the Agency) motion for summary judgment on September 30, 2021, against claims brought by a group of...more

Faegre Drinker Biddle & Reath LLP

The FDA Is in the Doghouse

An unusual pet food case filed this summer in the District Court of Colorado has a pet food manufacturer as the plaintiff rather than a defendant. Lystn, LLC v. FDA, No. 1:19CV01943 (D. Colo. July 5, 2019)....more

Wilson Sonsini Goodrich & Rosati

FDA Issues Cannabidiol Marketing Warning as Congressional Pressure for Action Continues

Following through with its promise to take enforcement actions against companies marketing cannabis-derived products that could put consumers at risk, the Food and Drug Administration (FDA) recently issued a warning letter to...more

Foley & Lardner LLP

FDA Marketing Exclusivity Periods Limited To Same Active Moiety

Foley & Lardner LLP on

In Otsuka Pharm. Co., Ltd. v. Price, No. 16-5229 (D.C. Cir. Aug. 29, 2017), the U.S. Court of Appeals for the District of Columbia Circuit affirmed the district court decision upholding FDA’s “same moiety” test for defining...more

Morgan Lewis

Lawsuit Challenges GRAS Rule on Food Substance Safety

Morgan Lewis on

Public interest groups challenge FDA’s “Generally Recognized as Safe” Rule as failing to ensure food ingredients are safe for consumers....more

Clark Hill PLC

DELAYED: The FDA’s Intended Use Rule

Clark Hill PLC on

The effective date of FDA’s Intended Use Rule has been extended until March 19, 2018. The comment period will remain open until May 19, 2017....more

Bergeson & Campbell, P.C.

EPA’s OCSPP Agrees to More Communication, Transparency, and Efficiency When Processing Pesticide Petitions

On October 27, 2015, the U.S. Environmental Protection Agency’s (EPA) Office of Inspector General (OIG) issued a report on an evaluation conducted by OIG entitled “EPA Needs Policies and Procedures to Manage Public Pesticide...more

Arnall Golden Gregory LLP

It’s Déjà Vu All Over Again: FDA Sued Again in Off-Label Promotion Case

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

McGuireWoods LLP

Otsuka’s Pediatric Labeling Dispute Seeks to Expand Orphan Drug Exclusivity

McGuireWoods LLP on

On April 13, 2015, the U.S. District Court for the District of Maryland issued an Order granting Otsuka Pharmaceutical Co., Ltd. Otsuka Pharmaceutical Development and Commercialization, Inc., and Otsuka America...more

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