PREVOR v. U.S. FOOD AND DRUG ADMIN.

Civil Action No. 13-1177 (RMC).

67 F.Supp.3d 125 (2014)

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

United States District Court, District of Columbia.

Signed September 9, 2014.


Attorney(s) appearing for the Case

Eric P. Gotting , Keller & Heckman, LLP, Jeffrey N. Gibbs , Jennifer McVey Thomas , John Robert Fleder , Anne K. Walsh , Hyman, Phelps & McNamara, P.C., Washington, DC, for Plaintiff.

John William Medford Claud , Andrew E. Clark, U.S. Department of Justice, Washington, DC, for Defendant.


OPINION

After five years, Prevor and the Food and Drug Administration (FDA) continue to dispute whether Prevor's DiphoterineTM Skin Wash (DSW) should be regulated as a "drug" or a "medical device." By giving unduly expansive meanings to certain language in the Federal Food, Drug, and Cosmetic...

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