[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: 21CFR99.405]
[Page 456]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 99 DISSEMINATION OF INFORMATION ON UNAPPROVED/NEW USES FOR MARKETED
Subpart E Corrective Actions and Cessation of Dissemination
Sec. 99.405 Applicability of labeling, adulteration, and misbranding authority.
The dissemination of information relating to a new use for a drug or
device may constitute labeling, evidence of a new intended use,
adulteration, or misbranding of the drug or device if such dissemination
fails to comply with section 551 of the Federal Food, Drug, and Cosmetic
Act (the act) (21 U.S.C. 360aaa) and the requirements of this part. A
manufacturer's failure to exercise due diligence in submitting the
clinical studies that are necessary for the approval of a new use that
is the subject of information disseminated under this part or in
beginning or completing such clinical studies shall be deemed a failure
to comply with section 551 of the act and the requirements of this part.
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