Abstract
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References
1.United States v. Dotterweich , 320 U.S. 277 (1943 ); United States v. Park , 421 U.S. 658 (1975 ).
2.
21 C.F.R. § 312.52 (1991 ) (attached).
3.
21 C.F.R. § 312.52(a).
4.Id. .
5.
21 C.F.R. § 312.52(b).
6.
A division within the Center for Drug Evaluation and Research's Office of Compliance which is responsible for the review of clinical studies.
7.
21 C.F.R. § 312.52(a).