[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: 21CFR54.3]
[Page 292]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 54 FINANCIAL DISCLOSURE BY CLINICAL INVESTIGATORS--Table of Contents
Sec. 54.3 Scope.
The requirements in this part apply to any applicant who submits a
marketing application for a human drug, biological product, or device
and who submits covered clinical studies. The applicant is responsible
for making the appropriate certification or disclosure statement where
the applicant either contracted with one or more clinical investigators
to conduct the studies or submitted studies conducted by others not
under contract to the applicant.
Back to Top
© 2007 Betterchem Corp.
|
