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BIOTICS RESEARCH CORP. v. HECKLER

Nos. 82-5325, 82-5412.

710 F.2d 1375 (1983)

BIOTICS RESEARCH CORPORATION, et al., Plaintiffs-Appellants, v. Margaret HECKLER, Sec'y etc., et al., Defendants-Appellees. SEROYAL BRANDS, INC., et al., Plaintiffs-Appellants, v. Margaret HECKLER, Sec'y etc., et al., Defendants-Appellees.

United States Court of Appeals, Ninth Circuit.

Decided July 5, 1983.

Attorney(s) appearing for the Case

Kirkpatrick W. Dilling, Dilling, Dilling & Groneck, Chicago, Ill., for plaintiffs-appellants.

Barry Grossman, Dept. of Justice, Washington, D.C., for defendants-appellees.

Before WALLACE and FERGUSON, Circuit Judges, and GRANT, District Judge.

WALLACE, Circuit Judge:

Biotics Research Corporation (Biotics) and Seroyal Brands, Inc. (Seroyal) appeal from district court orders dismissing their complaints for injunctive and declaratory relief against the Food and Drug Administration (FDA). We are asked to decide whether a "regulatory letter" in which the FDA states that a firm has violated laws it administers and threatens enforcement action constitutes a final agency determination ripe for judicial review under...

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