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HHS - 21 CFR PART 314

APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG

active, Most Current
Organization: HHS
Publication Date: 1 April 2015
Status: active
Page Count: 88
scope:

Scope of this part.

(a) This part sets forth procedures and requirements for the submission to, and the review by, the Food and Drug Administration of applications and abbreviated applications to market a new drug under section 505 of the Federal Food, Drug, and Cosmetic Act, as well as amendments, supplements, and postmarketing reports to them.

(b) This part does not apply to drug products subject to licensing by FDA under the Public Health Service Act (58 Stat. 632 as amended (42 U.S.C. 201 et seq.)) and subchapter F of chapter I of title 21 of the Code of Federal Regulations.

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

Purpose.

The purpose of this part is to establish an efficient and thorough drug review process in order to: (a) Facilitate the approval of drugs shown to be safe and effective; and (b) ensure the disapproval of drugs not shown to be safe and effective. These regulations are also intended to establish an effective system for FDA's surveillance of marketed drugs. These regulations shall be construed in light of these objectives.

Document History

April 1, 2019
APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG
Scope of this part. (a) This part sets forth procedures and requirements for the submission to, and the review by, the Food and Drug Administration of applications and abbreviated applications to...
April 1, 2018
APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG
(a) This part sets forth procedures and requirements for the submission to, and the review by, the Food and Drug Administration of applications and abbreviated applications to market a new drug under...
April 1, 2017
APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG
(a) This part sets forth procedures and requirements for the submission to, and the review by, the Food and Drug Administration of applications and abbreviated applications to market a new drug under...
April 1, 2016
APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG
(a) This part sets forth procedures and requirements for the submission to, and the review by, the Food and Drug Administration of applications and abbreviated applications to market a new drug under...
21 CFR PART 314
April 1, 2015
APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG
Scope of this part. (a) This part sets forth procedures and requirements for the submission to, and the review by, the Food and Drug Administration of applications and abbreviated applications to...
April 1, 2014
APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG
Scope of this part. (a) This part sets forth procedures and requirements for the submission to, and the review by, the Food and Drug Administration of applications and abbreviated applications to...

References

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