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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

FDA agrees to finalize GRAS rule by August 2016
  • Shook Hardy & Bacon LLP
  • USA
  • October 24 2014

According to a proposed consent decree filed in a D.C. district court, the U.S. Food and Drug Administration (FDA) will "submit a final rule regarding

Federal Court of Appeals holds FDA lacks authority to rescind 510(k) clearance
  • Barnes & Thornburg LLP
  • USA
  • October 7 2014

The U.S. Court of Appeals for the District of Columbia recently held that the FDA lacks the authority to rescind a 510(k) clearance. In Ivy Sports

FDA to discuss Nutrition and Supplement Facts labels
  • Shook Hardy & Bacon LLP
  • USA
  • June 9 2014

The U.S. Food and Drug Administration has announced a June 26, 2014, public meeting in Washington, D.C., to discuss two proposed rules aimed at