Description
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “Requests for Reconsideration at the Division Level Under GDUFA.” This guidance provides recommendations on the procedures for applicants of abbreviated new drug applications (ANDAs) that wish to pursue a request for reconsideration within the review discipline at the division level or original signatory authority. This guidance reflects the most recent reauthorization of the Generic Drug User Fee Amendments (GDUFA III) and clarifies what matters are appropriate for requests for reconsideration. This guidance finalizes the draft guidance for industry of the same title issued on January 11, 2024.
Scope & Applicability
Product Classes
3topic of the guidance document
Abbreviated New Drug Application regulatory actions
Meetings for complex products under GDUFA III
Stakeholders
7entity submitting marketing applications
responsible for justifying omission of studies
Office of Regulatory Operations Associate Director tracks requests
individuals participating in the requested teleconference
individuals participating in the requested teleconference
Evaluates whether the request satisfies procedural factors
The individual who grants or denies the request for reconsideration
Regulatory Context
Attributes
4criteria for matters appropriate for reconsideration
Classification of an amendment to an ANDA
Classification of ANDA assessment status
The deadline for a response to the request for reconsideration
Related CFR Sections (4)
- 21CFR314.110§ 314.110 Complete response letter to the applicant.
(a) Complete response letter. FDA will send the applicant a complete response letter if the agency determines that we will not approve the application or abbreviated application in its present form for one or more of the reasons given in § 314.125 or § 314.127 , respectively.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 →
- 21CFR314.102§ 314.102 Communications between FDA and applicants.
(a) General principles. During the course of reviewing an application or an abbreviated application, FDA shall communicate with applicants about scientific, medical, and procedural issues that arise during the review process. Such communication may take the form of telephone conversations, letters, Read full regulation →
- 21CFR10.75§ 10.75 Internal agency review of decisions.
(a) A decision of an FDA employee, other than the Commissioner, on a matter, is subject to review by the employee's supervisor under the following circumstances:Read full regulation →
See Also (8)
- Guidance for Review Staff and Industry Good Review Management Principles and Practices for PDUFA Products (Status: Draft)
- Failure to Respond to an ANDA Complete Response Letter Within the Regulatory Timeframe Guidance for Industry: Guidance for Industry (Status: Final)
- Quantitative Labeling of Sodium, Potassium, and Phosphorus for Human Over-the-Counter and Prescription Drug Products (Status: Draft)
- Formas posológicas orales sólidas de liberación inmediata Cambios de escala y posteriores a la aprobación: documentación química, de fabricación y controles, de pruebas de disolución in vitro y bioequivalencia in vivo. (Status: Final)
- SUPAC-IR: Immediate-Release Solid Oral Dosage Forms: Scale-Up and Post-Approval Changes: Chemistry, Manufacturing and Controls, In Vitro Dissolution Testing, and In Vivo Bioequivalence Documentation (Status: Final)
- SUPAC-SS: Nonsterile Semisolid Dosage Forms; Scale-Up and Post-Approval Changes: Chemistry, Manufacturing and Controls; In Vitro Release Testing and In Vivo Bioequivalence Documentation: Guidance for Industry (Status: Final)
- Extended Release Oral Dosage Forms: Development, Evaluation, and Application of In Vitro/In Vivo Correlations (Status: Final)
- SUPAC-MR: Modified Release Solid Oral Dosage Forms Scale-Up and Postapproval Changes: Chemistry, Manufacturing, and Controls; In Vitro Dissolution Testing and In Vivo Bioequivalence Documentation: Guidance for Industry (Status: Final)