Assessing User Fees Under the Prescription Drug User Fee Amendments of 2022 | Guideline Explorer

Description

This guidance provides information to stakeholders regarding FDA’s implementation of the Prescription Drug User Fee Amendments of 2022 (PDUFA VII) under Title I of the FDA User Fee Reauthorization Act of 2022. Because PDUFA VII created changes to the user fee program, this guidance explains the changes created by the statute which includes changes to certain definitions, changes to certain PDUFA fee exceptions, waivers, exemptions, reductions, and returns and certain changes for PDUFA invoicing procedures.

Scope & Applicability

Product Classes

8

Prescription Drug Product

Products subject to program fees; Specific strength or potency of a drug in final dosage form

Combination Product

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.

Biological Product

Regulated under section 351(i) of the PHS Act; Virus, therapeutic serum, toxin, vaccine, or protein applicable to prevention or treatment; Alternative regulation category for products meeting device definition

Human Drug Application

Defined as application for new drug approval or biological product licensure

Skin-Test Diagnostic Product

Product intended to detect skin hypersensitivity reactions; Exempt from prescription drug program fees

Orphan Drug

A drug intended for use in a rare disease or condition

Allergenic Extract Product

Products administered for diagnosis or treatment of allergies

large volume parenteral product

Exempt from prescription drug program fees if on specific list

Stakeholders

4

Applicant

Entity submitting development data and knowledge; Entity performing the work process for change

Small Business

Target audience for the compliance guide

Affiliate

An entity whose sales must be included in the calculation if it is related to the facility.; Facility that controls, is controlled by, or is under common control with another facility

Sponsor

Entity responsible for submitting applications under section 524B

Regulatory Context

Attributes

6

Final Dosage Form

Finished dosage form approved for administration without substantial further manufacturing

Gross Worldwide Revenue

Financial threshold of $50 million for orphan exemption

Clinical Data

Requirement for safety or effectiveness data determining fee level

pharmaceutically equivalent

Condition for fee exception

strength

requirement for sameness between generic and RLD

potency

Key search term and scientific factor for evaluation.

Related CFR Sections (4)

21CFR680.3§ 680.3 Tests.
(a) Identity. When a specific identity test meeting the provisions of § 610.14 of this chapter cannot be performed, the manufacture of each lot shall be separated from the manufacture of other products in a manner that will preclude adulteration, and records made in the course of manufacture shall bRead 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 →
21CFR3.2§ 3.2 Definitions.
For the purpose of this part: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 →