Quimbee logo with url
From our private database of 14,900+ case briefs...

Syncor International Corp. v. Shalala

United States Court of Appeals for the District of Columbia Circuit
127 F.3d 90 (1997)


In 1995, the federal Food and Drug Administration (FDA) (defendant) issued a notice concerning positron emission tomography technology (PET) and PET-manufactured pharmaceutical drugs. The Administrative Procedure Act’s (APA’s), 5 U.S.C. § 551 et seq., notice and comment procedures require a federal agency both to notify the public of the agency’s intention and to give the public an opportunity to comment on the agency’s proposal before issuing any substantive rules or policies. However, the APA’s notice and comment procedures do not apply to an agency’s nonsubstantive statements. The FDA characterized the 1995 PET notice as a nonsubstantive guidance or policy statement. Accordingly, it did not provide any notice and comment before issuing the 1995 notice. The 1995 notice stated that it superseded a 1984 FDA guideline concerning PET drugs. The 1984 guideline explicitly stated that the Federal Food, Drugs, and Cosmetics Act (FFDCA), 21 U.S.C. § 301 et seq., did not apply to PET drugs. However, the 1995 notice reversed that position and explicitly stated that PET drugs would now need to comply with the FFDCA. Syncor International Corporation (Syncor) (plaintiff) sued the FDA, contending that the FDA’s 1995 notice was a substantive rule, and, therefore, the APA’s notice and comment requirements should have been followed before the FDA issued it. The district court found that the 1995 notice was a nonsubstantive interpretative rule, and, therefore, notice and comment procedures were not required before issuing it. Syncor appealed to the United States Court of Appeals for the District of Columbia Circuit.

Rule of Law


Holding and Reasoning (Silberman, J.)

What to do next…

  1. Unlock this case brief with a free (no-commitment) trial membership of Quimbee.

    You’ll be in good company: Quimbee is one of the most widely used and trusted sites for law students, serving more than 97,000 law students since 2011. Some law schools—such as Yale, Vanderbilt, Berkeley, and the University of Illinois—even subscribe directly to Quimbee for all their law students. Read our student testimonials.

  2. Learn more about Quimbee’s unique (and proven) approach to achieving great grades at law school.

    Quimbee is a company hell-bent on one thing: helping you get an “A” in every course you take in law school, so you can graduate at the top of your class and get a high-paying law job. We’re not just a study aid for law students; we’re the study aid for law students. Read more about Quimbee.

Here's why 284,000 law students have relied on our case briefs:

  • Written by law professors and practitioners, not other law students. 14,900 briefs, keyed to 201 casebooks. Top-notch customer support.
  • The right amount of information, includes the facts, issues, rule of law, holding and reasoning, and any concurrences and dissents.
  • Access in your classes, works on your mobile and tablet. Massive library of related video lessons and high quality multiple-choice questions.
  • Easy to use, uniform format for every case brief. Written in plain English, not in legalese. Our briefs summarize and simplify; they don’t just repeat the court’s language.