C.F.R. » Title 21 » CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER A—GENERAL › PART 14—PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE › Subpart I—Advisory Committees for Human Prescription Drugs

21 C.F.R. § 14.160

Establishment of standing technical advisory committees for human prescription drugs

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The standing technical advisory committees for human prescription drugs are established to advise the Commissioner:

(a) Generally on the safety and effectiveness, including the labeling and advertising, and regulatory control of the human prescription drugs falling within the pharmacologic class covered by the advisory committee and on the scientific standards appropriate for a determination of safety and effectiveness in that class of drugs.

(b) Specifically on any particular matter involving a human prescription drug pending before FDA, including whether the available information is adequate to support a determination that—

(1) A particular IND study may properly be conducted;

(2) A particular drug meets the statutory standard for proof of safety and effectiveness necessary for approval or continued approval for marketing; or

(3) A particular drug is properly classified as a new drug, an old drug, or a banned drug.

Notes of Decisions
Cited in 2 cases, 2008–2020 · leading case: Horne v. Novartis Pharm. Corp., 541 F. Supp. 2d 768 (W.D.N.C. 2008).
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Horne v. Novartis Pharm. Corp., 541 F. Supp. 2d 768 (W.D.N.C. 2008). “21 C.F.R. § 14.160 . If, after reviewing the application, the FDA finds that the drug is safe and effective for its intended use and that the labeling is not false or misleading, the FDA will send an approval letter to the applicant.”
Smith v. Antares Pharma, Inc. (D.N.J. 2020). “See 21 CFR §§ 14.160 , 14.171. Letter”) stating that the FDA had “identified deficiencies that preclude the continuation of the discussion of labeling and post[-]marketing requirements/commitments [for QST] at this time.”
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