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PREVOR v. FOOD AND DRUG ADMIN.

Civil Action No. 11-1187 (RMC).

895 F.Supp.2d 90 (2012)

PREVOR, Plaintiff, v. FOOD AND DRUG ADMINISTRATION, Defendant.

United States District Court, District of Columbia.

September 25, 2012.

Attorney(s) appearing for the Case

John Robert Fleder , Anne K. Walsh , Jeffrey N. Gibbs , Hyman, Phelps & McNamara, P.C., Washington, DC, for Plaintiff.

John William Medford Claud , U.S. Department of Justice, Consumer Protection Branch, Washington, DC, for Defendant.

OPINION

ROSEMARY M. COLLYER, District Judge.

PREVOR, a French company, developed a product called Diphoterine™ Skin Wash ("DSW") to mitigate chemical burn injuries in the industrial workplace. PREVOR sues the Food and Drug Administration for declaratory and injunctive relief to change FDA's designation of DSW as a drug-device combination product with a "drug" primary mode of action. PREVOR claims that FDA erred and thereby violated the Federal Food...

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