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Oral Argument Held in Deeming Rule Appeal by Nicopure Labs and Right to be Smoke-Free Coalition
  • Keller and Heckman LLP
  • USA
  • September 26 2018

On September 11, 2018, Nicopure Labs, LLC and the Right to be Smoke-Free Coalition (the “Appellants”) appeared for oral argument before a three-judge


Kombucha Decision Highlights Risk of Marketing Foods Not Defined by FDA
  • McGuireWoods LLP
  • USA
  • September 26 2018

The recent denial of a tea manufacturer’s motion to dismiss in the Southern District of California demonstrates the risks food manufacturers face when


Deeming Regulations Litigation Update-U.S. District Court for the District of Columbia Expected Forum for Three Appointments Clause Challenges
  • Troutman Sanders LLP
  • USA
  • July 30 2018

The FDA has advanced in its “procedural maneuvering” in three constitutional challenges to the Deeming Regulations. The challenges - premised on the


Deeming Regulations Litigation Update-New Challenges Filed on Behalf of Vapor Plaintiffs
  • Troutman Sanders LLP
  • USA
  • February 12 2018

A series of challenges to the Deeming Regulations has recently been filed by several vapor-product manufacturers, retailers, and a non-profit


FDA Marketing Exclusivity Periods Limited To Same Active Moiety
  • Foley & Lardner LLP
  • USA
  • September 7 2017

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


Three-Year Exclusivity Bar Only Blocks Subsequent Applications for Drugs with the Same Active Moiety
  • McDermott Will & Emery
  • USA
  • November 11 2016

Addressing a question of statutory interpretation regarding the meaning of the applicable exclusivity provisions of the Federal Food, Drug, and


Right To Be Smoke Free Coalition and E-Vapor Industry Trade Associations File Lawsuit Challenging FDA's Deeming Regulation and the Tobacco Control Act
  • Keller and Heckman LLP
  • USA
  • June 21 2016

On behalf of the Right To Be Smoke Free Coalition and the entire e-vapor industry, yesterday Keller and Heckman LLP filed a Complaint in the U.S


FMSA implementation strategies focus of upcoming FDA meeting
  • Shook Hardy & Bacon LLP
  • USA
  • April 3 2015

The U.S. Food and Drug Administration (FDA) has established a docket for comments related to the agency's implementation of food safety standards


Recent court decision clarifies some 505(b)(2) NDA issues and what it might mean for industry
  • Arnall Golden Gregory LLP
  • USA
  • February 16 2015

In January 2015, the United States District Court of the District of Columbia issued an opinion, supporting the Food and Drug Administration’s (FDA)


Orphan drug exclusivity criteria clarified in court decision
  • Arnall Golden Gregory LLP
  • USA
  • October 28 2014

A U.S. District Court has issued a decision that could affect the Food and Drug Administration's interpretation and determination in the orphan drug