Assessing User Fees Under the Generic Drug User Fee Amendments of 2022

Description

This guidance provides information to stakeholders regarding FDA’s implementation of the Generic Drug User Fee Amendments of 2022 (GDUFA III) under Title III of the FDA User Fee Reauthorization Act of 2022. Because GDUFA III created changes to the user fee structure, this guidance serves to provide an explanation about the new fee structure and types of fees for which entities are responsible.

Key Topics

Terms and concepts identified from this document

Scope & Applicability

Product Classes

3

Finished Dosage Form

drug product with multi-level packaging

FDF

Finished Dosage Form manufacturer facility

Positron Emission Tomography Drug

Requirement to comply with eCTD could adversely impact development of PET drugs.

Stakeholders

10

Contract Manufacturing Organization

An FDF manufacturer facility not identified in an approved ANDA held by the owner

FDA forms manager

Contact person for assistance with accessing FDA forms.

affiliate

Entity that controls or is controlled by the applicant; Business entities related to the applicant

ANDA applicant

Entity that has submitted an ANDA to the FDA; Entity requesting meetings with FDA; Entity seeking a post-submission meeting; party responsible for reviewing minutes and notifying FDA of disagreements

Repackager

Trading partner required to have verification systems; Trading partner required to have verification systems in place.; Trading partner required to validate transaction history and verify product identifiers; must quarantine illegitimate product; receives returned product that it intends to further distribute

Packager

Considered manufacturers for GDUFA fee purposes

Contract Manufacturing Organizations

Facility fee requirements for CMOs; CMOs qualifying for reduced facility fees

Packagers

Entities subject to facility fee considerations

Repackagers

Entities subject to facility fee considerations

Affiliates

Single fee for an ANDA applicant and its affiliates

Regulatory Context

Regulatory Activities

8

Abbreviated New Drug Application

ANDA submission containing a waiver request

Type II API DMF

Drug Master File for active pharmaceutical ingredients

GDUFA User Fee Program

Fee structure and assessment

GDUFA III

second reauthorization of the Generic Drug User Fee Amendments

PDUFA

Prescription Drug User Fee Act products

BsUFA

Biosimilar User Fee Act products

ANDA

Abbreviated New Drug Application

Prior Approval Supplement

Major changes requiring FDA approval before implementation

Document Types

7

Drug Master File

A submission to FDA that may be used to provide confidential information about facilities or processes.; cross-referencing a DMF in a BLA

Articles of Incorporation

Required documentation for size determination

Generic Drug User Fee Cover Sheet

Document generated to track user fee payments

post-approval supplement

Submission type to remove a facility from an ANDA

Type II Active Pharmaceutical Ingredient Drug Master File

Submission of information to support approval of a generic drug submission

Type II Drug Master Files – Available for Reference List

List of DMFs that have passed completeness assessment

Orange Book

Approved Drug Products With Therapeutic Equivalence Evaluations

Attributes

5

Dual Operation Facilities

Facilities that incur only FDF facility fees

Large-size operation

Tier for companies with 20 or more approved ANDAs

Medium-size operation

Tier for companies with 6 to 19 approved ANDAs

Small-size operation

Tier for companies with 5 or fewer approved ANDAs

Finished Dosage Form

Drug product in the form in which it will be administered to a patient

Technical Details

Substances

2

Active Pharmaceutical Ingredient

examples of such components include but are not limited to the active moiety (API)

API

Active Pharmaceutical Ingredient

Testing Methods

1

Testing

Facilities solely engaged in testing do not incur facility fees

Processes

3

Lyophilization

Physical modification that does not result in chemical alteration.; A process that does not typically chemically alter an ingredient

Repackaging

Activity that does not incur facility fees

Relabeling

Activity that does not incur facility fees

Related CFR Sections (6)

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 →
21CFR314.101§ 314.101 Filing an NDA and receiving an ANDA.
(a) Filing an NDA.Read full regulation →
21CFR207.1§ 207.1 What definitions and interpretations of terms apply to this part?
The definitions and interpretations of terms in sections 201 and 510 of the Federal Food, Drug, and Cosmetic Act apply to the terms used in this part, if not otherwise defined in this section. The following definitions apply to this part:Read full regulation →
21CFR314.81§ 314.81 Other postmarketing reports.
(a) Applicability. Each applicant shall make the reports for each of its approved applications and abbreviated applications required under this section and section 505(k) of the act.Read full regulation →
21CFR314.70§ 314.70 Supplements and other changes to an approved NDA.
(a) Changes to an approved NDA.Read 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 →

Enforcement Impact

Deficiencies cited in Warning Letters referencing the same regulations

False or misleading risk presentation

4

Failure to submit under Form FDA-2253

3

Failure to submit promotional materials

2

Omission of material facts

2

False or misleading claims about efficacy and risks

1

False or misleading promotional communication

1

Failure to submit promotional materials at time of initial dissemination

1

False or Misleading Risk Presentation

1

Omission of Material Facts

1

Failure to Submit Under Form FDA-2253

1