UNLIMITED FREE ACCESS TO THE WORLD'S BEST IDEAS

close
Already an Engineering360 user? Log in.

This is embarrasing...

An error occurred while processing the form. Please try again in a few minutes.

Customize Your Engineering360 Experience

close
Privacy Policy

This is embarrasing...

An error occurred while processing the form. Please try again in a few minutes.

HHS - 21 CFR PART 312

INVESTIGATIONAL NEW DRUG APPLICATION

active, Most Current
Organization: HHS
Publication Date: 1 April 2014
Status: active
Page Count: 44
scope:

(a) This part contains procedures and requirements governing the use of investigational new drugs, including procedures and requirements for the submission to, and review by, the Food and Drug Administration of investigational new drug applications (IND's). An investigational new drug for which an IND is in effect in accordance with this part is exempt from the premarketing approval requirements that are otherwise applicable and may be shipped lawfully for the purpose of conducting clinical investigations of that drug.

(b) References in this part to regulations in the Code of Federal Regulations are to chapter I of title 21, unless otherwise noted.

Applicability. Except as provided in this section, this part applies to all clinical investigations of products that are subject to section 505 of the Federal Food, Drug, and Cosmetic Act or to the licensing provisions of the Public Health Service Act (58 Stat. 632, as amended (42 U.S.C. 201 et seq.)).

Document History

April 1, 2019
INVESTIGATIONAL NEW DRUG APPLICATION
(a) This part contains procedures and requirements governing the use of investigational new drugs, including procedures and requirements for the submission to, and review by, the Food and Drug...
April 1, 2018
INVESTIGATIONAL NEW DRUG APPLICATION
(a) This part contains procedures and requirements governing the use of investigational new drugs, including procedures and requirements for the submission to, and review by, the Food and Drug...
April 1, 2017
INVESTIGATIONAL NEW DRUG APPLICATION
(a) This part contains procedures and requirements governing the use of investigational new drugs, including procedures and requirements for the submission to, and review by, the Food and Drug...
April 1, 2016
INVESTIGATIONAL NEW DRUG APPLICATION
(a) This part contains procedures and requirements governing the use of investigational new drugs, including procedures and requirements for the submission to, and review by, the Food and Drug...
April 1, 2015
INVESTIGATIONAL NEW DRUG APPLICATION
(a) This part contains procedures and requirements governing the use of investigational new drugs, including procedures and requirements for the submission to, and review by, the Food and Drug...
21 CFR PART 312
April 1, 2014
INVESTIGATIONAL NEW DRUG APPLICATION
(a) This part contains procedures and requirements governing the use of investigational new drugs, including procedures and requirements for the submission to, and review by, the Food and Drug...
Advertisement