N.J. Admin. Code § 8:21-4.5

Current through Register Vol. 56, No. 12, June 17, 2024

Section 8:21-4.5 - General provisions; new drug applications

(a)21 C.F.R. 314.1(Applications), 21 C.F.R. 314.60 (Amended applications), 21 C.F.R. 314.65 (Withdrawal of applications without prejudice), 21 C.F.R. 314.70 (Supplemental applications), 21 C.F.R. 314.90 (Insufficient information in application), 21 C.F.R. 314.105 (New drug application approvals; notification to applicant of approval of application; availability of information), 21 C.F.R. 314.420 (Master files), 21 C.F.R. 314.12 (Untrue statements in application), 21 C.F.R. 314.104 (New drugs with potential for abuse) and 21 C.F.R. 314.140 (Confidentiality of data and information in a new drug application, NDA, file) are hereby adopted by reference.

(b) Subpart B (Administrative actions on applications), 21 C.F.R. 314.102 (Comment on application), 21 C.F.R. 314.125 (Reasons for refusing to file applications), 21 C.F.R. 314.125 (Reasons for refusing to file applications), 21 C.F.R. 314.120 (Refusal to approve the application), 21 C.F.R. 314.150 (Withdrawal of approval of an application), 21 C.F.R. 314.152 (Notice of withdrawal of approval of application), 21 C.F.R. 314.160 (Revocation of order refusing to approve application, or suspending or withdrawing approval of an application), and 21 C.F.R. 314.162 (Notices and orders) are hereby adopted by reference.

(c) Full text of Federal regulations pertaining to new drugs, incorporated herein by reference, may be found at sections 310, 312 and 314 of 21 C.F.R., parts 300 through 499, revised as of April 11, 1989 and may be purchased from:

Superintendent of Documents

United States Government Printing Office

Washington, D.C. 20402

(d) The complete text of those sections adopted by the Department may be reviewed in the:

New Jersey Department of Health and Senior Services

Consumer and Environmental Health Services

PO Box 369

Trenton, New Jersey 08625-0369

N.J. Admin. Code § 8:21-4.5

Amended by R.1987 d.226, effective 5/18/1987.
See: 18 New Jersey Register 2363(a), 19 New Jersey Register 873(a).
21 C.F.R. numbers changed; price raised from $ 5.00 to $ 25.00 and address changed.
Correction: Text was omitted from (a) "notification to applicant of approval of application".
See: 19 New Jersey Register 1342(b).
Amended by R.1990 d.563, effective 11/19/1990.
See: 22 New Jersey Register 2465(a), 22 New Jersey Register 3559(a).
Stylistic changes.
Amended by R.2000 d.427, effective 10/16/2000.
See: 32 New Jersey Register 2386(a), 32 New Jersey Register 3831(a).
In (c), deleted a reference to price; and in (d), changed name and address.