Description
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “ANDAs: Pre-Submission Facility Correspondence Related to Prioritized Generic Drug Submissions.” This guidance describes the facility information to be submitted in a pre-submission facility correspondence (PFC) and how FDA will use this information to set a review goal for a priority abbreviated new drug application (ANDA). This guidance incorporates a program enhancement agreed upon by the Agency and industry as part of the negotiations relating to reauthorization of the Generic Drug User Fee Amendments (GDUFA) and as described in “GDUFA Reauthorization Performance Goals and Program Enhancements Fiscal Years 2023-2027” (GDUFA III commitment letter). This guidance finalizes for implementation the draft guidance of the same title issued on December 5, 2022.
Scope & Applicability
Product Classes
2Subject of GDUFA and related meeting processes.
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.
Stakeholders
1Entity submitting development data and knowledge; Entity performing the work process for change
Regulatory Context
Attributes
3Determining whether an ANDA qualifies for priority review; 8-month review timeline for prioritized ANDAs; 8-month review goal date
Physical, chemical, biological, or microbiological properties
10-month review timeline for non-priority ANDAs
Related CFR Sections (3)
- 21CFR320.24§ 320.24 Types of evidence to measure bioavailability or establish bioequivalence.
(a) Bioavailability may be measured or bioequivalence may be demonstrated by several in vivo and in vitro methods. FDA may require in vivo or in vitro testing, or both, to measure the bioavailability of a drug product or establish the bioequivalence of specific drug products. Information on bioequivRead full regulation →
- 21CFR314.94§ 314.94 Content and format of an ANDA.
ANDAs are required to be submitted in the form and contain the information required under this section. Three copies of the ANDA are required, an archival copy, a review copy, and a field copy. FDA will maintain guidance documents on the format and content of ANDAs to assist applicants in their prepRead full regulation →
- 21CFR314.70§ 314.70 Supplements and other changes to an approved NDA.
(a) Changes to an approved NDA.Read full regulation →
Related Warning Letters (4)
- 2025-03-18
CGMP/Finished Pharmaceutical/Adulterated
Advanced Pharmaceutical Technology
- 2024-08-27
CGMP/Drugs/Adulterated
EyePoint Pharmaceuticals, Inc.
- 2024-08-06
CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug
Omega Tech Labs LLC
- 2021-06-29
Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA)
Aquavit Pharmaceuticals, Inc
See Also (8)
- ANDAs: Pre-Submission of Facility Information Related to Prioritized Generic Drug Applications (Pre-Submission Facility Correspondence) Guidance for Industry (Status: Draft)
- Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application (Status: Draft)
- Bioavailability Studies Submitted in NDAs or INDs – General Considerations (Status: Final)
- Alternate Source of the Active Pharmaceutical Ingredient in Pending ANDAs: Guidance for Industry (Status: Final)
- Food-Effect Bioavailability and Fed Bioequivalence Studies: Guidance for Industry (Status: Final)
- Submission of Summary Bioequivalence Data for Abbreviated New Drug Applications (Status: Final)
- Safety Reporting Requirements for INDs (Investigational New Drug Applications) and BA/BE (Bioavailability/Bioequivalence) Studies: Guidance for Industry and Investigators (Status: Final)
- ANDA Submissions — Content and Format of Abbreviated New Drug Applications: Guidance for Industry (Status: Final)