New Jersey Administrative Code
Title 8 - HEALTH
Chapter 21 - FOOD AND DRUGS
Subchapter 4 - NEW DRUGS
Section 8:21-4.4 - Exemptions from section 505(a)

Universal Citation: NJ Admin Code 8:21-4.4

Current through Register Vol. 56, No. 18, September 16, 2024

(a) 21 C.F.R. 312.1 (Conditions for exemption of new drugs for investigational use), 21 C.F.R. 312.5 (Confidentiality of data and information in an investigational new drug notice, IND), and 21 C.F.R. 312.9 (New drugs for investigational use in laboratory research animals or in vitro tests) are hereby adopted by reference.

(b) Regarding subpart B (Controlled substances), 21 C.F.R. 312.10, Availability of records, is hereby adopted by reference.

(c) Regarding subpart C (International research), 21 C.F.R. 312.20, Clinical data generated outside the United States and not subject to a "Notice of Claimed Investigational Exemption of a New Drug", is hereby adopted by reference.

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