# 21 CFR § 314.2: Purpose

> Federal · Regulations · In force

URL: https://www.frixlaw.com/law-library/statutes/ecfr-21-314.2

## Section

- **Citation:** 21 CFR § 314.2
- **Heading:** Purpose
- **Jurisdiction:** Federal
- **Kind:** Regulations
- **Status:** In force
- **Text as of:** September 22, 2026
- **Source:** Publisher's official text
- **Location:** Title 21—Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER D—DRUGS FOR HUMAN USE > PART 314—APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG > Subpart A—General Provisions

## Text

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.

## Nearby sections

- [21 CFR § 314.1 § 314.1 Scope of this part.](https://www.frixlaw.com/law-library/statutes/ecfr-21-314.1.md)
- [21 CFR § 314.2 § 314.2 Purpose.](https://www.frixlaw.com/law-library/statutes/ecfr-21-314.2.md)
- [21 CFR § 314.3 § 314.3 Definitions.](https://www.frixlaw.com/law-library/statutes/ecfr-21-314.3.md)
- [21 CFR § 314.50 § 314.50 Content and format of an NDA.](https://www.frixlaw.com/law-library/statutes/ecfr-21-314.50.md)
- [21 CFR § 314.52 § 314.52 Notice of certification of invalidity, unenforceability, or noninfringement of a patent.](https://www.frixlaw.com/law-library/statutes/ecfr-21-314.52.md)
- [21 CFR § 314.53 § 314.53 Submission of patent information.](https://www.frixlaw.com/law-library/statutes/ecfr-21-314.53.md)
- [21 CFR § 314.54 § 314.54 Procedure for submission of a 505(b)(2) application requiring investigations for approval of a new indication for, or other change from, a listed drug.](https://www.frixlaw.com/law-library/statutes/ecfr-21-314.54.md)
- [21 CFR § 314.55 § 314.55 Pediatric use information.](https://www.frixlaw.com/law-library/statutes/ecfr-21-314.55.md)
- [21 CFR § 314.56 § 314.56 Nonprescription drug product with an additional condition for nonprescription use (ACNU).](https://www.frixlaw.com/law-library/statutes/ecfr-21-314.56.md)
- [21 CFR § 314.60 § 314.60 Amendments to an unapproved NDA, supplement, or resubmission.](https://www.frixlaw.com/law-library/statutes/ecfr-21-314.60.md)
- [21 CFR § 314.65 § 314.65 Withdrawal by the applicant of an unapproved application.](https://www.frixlaw.com/law-library/statutes/ecfr-21-314.65.md)
- [21 CFR § 314.70 § 314.70 Supplements and other changes to an approved NDA.](https://www.frixlaw.com/law-library/statutes/ecfr-21-314.70.md)
- [21 CFR § 314.71 § 314.71 Procedures for submission of a supplement to an approved application.](https://www.frixlaw.com/law-library/statutes/ecfr-21-314.71.md)
- [21 CFR § 314.72 § 314.72 Change in ownership of an application.](https://www.frixlaw.com/law-library/statutes/ecfr-21-314.72.md)

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Source: Frix Law Library, https://www.frixlaw.com/law-library/statutes/ecfr-21-314.2. Check the current official text before relying on it. Not legal advice.