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SYNCOR INTERN. CORP. v. SHALALA

No. 96-5371.

127 F.3d 90 (1997)

SYNCOR INTERNATIONAL CORPORATION, et al., Appellants, v. Donna E. SHALALA, Secretary of Health and Human Services, et al., Appellees.

United States Court of Appeals, District of Columbia Circuit.

Decided October 28, 1997.

Attorney(s) appearing for the Case

Alvin J. Lorman, Washington, DC, argued the cause for appellants, with whom Gregory R. Firehock was on the briefs.

Jay I. Bratt, Attorney, United States Department of Justice, Washington, DC, argued the cause for appellees, with whom Frank W. Hunger, Assistant Attorney General, and Eric H. Holder, Jr., U.S. Attorney at the time the briefs were filed, were on the brief.

Before: SILBERMAN, ROGERS and TATEL, Circuit Judges.

Opinion for the Court filed by Circuit Judge SILBERMAN.

SILBERMAN, Circuit Judge:

Appellants Syncor International Corporation, American College of Nuclear Physicians, Society of Nuclear Medicine, and American Pharmaceutical Association (collectively, Syncor) appeal the district court's decision that FDA's 1995 "Notice," entitled "Regulation of Positron Emission Tomography Radiopharmaceutical Drug Products; Guidance; Public Workshop," was a "non-substantive...

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