Description
This guidance identifies the types of applications that are covered by section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act (the Act). A 505(b)(2) application is a new drug application (NDA) described in section 505(b)(2) of the Act. It is submitted under section 505(b)(1) of the Act and approved under section 505(c) of the Act. This guidance also provides further information and amplification regarding FDA's regulations at 21 CFR 314.54.
Scope & Applicability
Product Classes
4permitting approval under 505(j) of duplicates of approved drugs (listed drugs)
An NCE for which a 505(b)(2) application may be submitted using published studies.
Products combining drug, device, or biological constituents; Generally recommended for Enhanced Documentation; Requires 14971-based framework incorporating ICH Q9; A drug-device combination where the device constituent part detects ingestion.
Specific requirements for New Chemical Entities
Stakeholders
2entity submitting marketing applications
Entity responsible for submitting applications under section 524B
Regulatory Context
Attributes
2sponsor obtains a right of reference to submit the reports of studies.
A state where rate or extent of absorption differs from 505(j) standards.
Related CFR Sections (7)
- 21CFR314.54§ 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.
(a) The Federal Food, Drug, and Cosmetic Act does not permit approval of an ANDA for a new indication, nor does it permit approval of other changes in a listed drug if investigations, other than bioavailability or bioequivalence studies, are essential to the approval of the change. Any person seekinRead full regulation →
- 21CFR314.101§ 314.101 Filing an NDA and receiving an ANDA.
(a) Filing an NDA.Read full regulation →
- 21CFR314.50§ 314.50 Content and format of an NDA.
NDAs and supplements to approved NDAs are required to be submitted in the form and contain the information, as appropriate for the particular submission, required under this section. Three copies of the NDA are required: An archival copy, a review copy, and a field copy. An NDA for a new chemical enRead full regulation →
- 21CFR314.108§ 314.108 New drug product exclusivity.
(a) Definitions. The definitions in § 314.3 and the following definitions of terms apply to this section:Read full regulation →
- 21CFR60.3§ 60.3 Definitions.
(a) The definitions contained in 35 U.S.C. 156 apply to those terms when used in this part.Read full regulation →
- 21CFR314.3§ 314.3 Definitions.
(a) The definitions and interpretations contained in section 201 of the Federal Food, Drug, and Cosmetic Act apply to those terms when used in this part and part 320 of this chapter .Read full regulation →
- 21CFR320.1§ 320.1 Definitions.
The definitions contained in § 314.3 of this chapter apply to those terms when used in this part.Read full regulation →
See Also (8)
- Levothyroxine Sodium Products Enforcement of August 14, 2001 Compliance Date and Submission of New Applications (Status: Final)
- Refuse to File: NDA and BLA Submissions to CDER Guidance for Industry (Status: Draft)
- Determining Whether to Submit an ANDA or a 505(b)(2) Application (Status: Final)
- Format and Content of the Clinical and Statistical Sections of an Application (Status: Final)
- PET Drug Applications - Content and Format for NDAs and ANDAs_2011 (Status: Final)
- Fixed-Combinations and Single-Entity Versions of Previously Approved Antiretrovirals for the Treatment or Prevention of Human Immunodeficiency Virus-One Under the President’s Emergency Plan for Acquired Immunodeficiency Syndrome Relief (Status: Draft)
- Environmental Assessment of Human Drug and Biologics Applications: Guidance for Industry (Status: Final)
- Reference Product Exclusivity for Biological Products Filed Under Section 351(a) of the PHS Act (Status: Draft)