[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR14.160]
[Page 161]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 14 PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE--Table of Contents
Subpart I Advisory Committees for Human Prescription Drugs
Sec. 14.160 Establishment of standing technical advisory committees for
human prescription drugs.
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.
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