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GDUFA REAUTHORIZATION PERFORMANCE GOALS AND PROGRAM ENHANCEMENTS FISCAL YEARS 20182022 I. SUBMISSION REVIEW PERFORMANCE GOALS A. Original ANDAs and ANDA Amendments B. PASs and PAS Amendments C. Unsolicited.

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Related content

GDUFA II Commitment Letter - FDA
May 12, 2016 — User Fee Act (GDUFA) reauthorization for Fiscal Years (FYs) 2018-2022...
Learn more
Improving Generic Drug Approval at the FDA...
Apr 26, 2018 — [hereinafter GDUFA II LETTER]; FOOD & DRUG ADMIN., PDUFA COMMITMENT...
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GDUFA requires reauthorization every five years, with GDUFA II currently in place through September 2022.

GDUFA authorizes the Food and Drug Administration (FDA) to collect fees from drug companies that submit marketing applications for certain generic human drug applications, certain drug master files, and certain facilities.

GDUFA authorizes the Food and Drug Administration (FDA) to collect fees from drug companies that submit marketing applications for certain generic human drug applications, certain drug master files, and certain facilities.

Under the GDUFA II framework, correspondence seeking regulatory and/or scientific advice after issuance of a Complete Response Letter or tentative approval, or after ANDA approval, was considered general correspondence. Under GDUFA III, these types of correspondence can be submitted as controlled correspondence.

The implementation of the Generic Drug User Fee Amendments (GDUFA) encompasses a wide range of activities that fall within the scope of regulating the generic drug industry. GDUFA was reauthorized on September 30, 2022 (GDUFA III), with provisions that are in effect from October 1, 2022, through September 30, 2027.

Facility Fees. What are the fee facility fee types under GDUFA III? There are three types of facility fees: (1) an active pharmaceutical ingredient (API) facility fee; (2) finished dosage form (FDF) facility fee; and (3) Contract Manufacturing Organization (CMO) facility fee.

GDUFA and PDUFA are US FDA programs that are designed to help the agency hire and retain a sufficient number and types of technical and scientific experts to evaluate human drug applications (NDAs and ANDAs) efficiently and predictably. GDUFA is associated with ANDAs, whereas PDUFA is associated with NDAs.

An improvement under GDUFA II comes in the form of a partial application fee refund offered for withdrawal of an ANDA application prior to being received. Under GDUFA I, Sponsors had no incentive to withdraw and correct an application, even if they become aware of a fatal flaw in the application.

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© Copyright 1997-2025
airSlate Legal Forms, Inc.
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Form Packages
Adoption
Bankruptcy
Contractors
Divorce
Home Sales
Employment
Identity Theft
Incorporation
Landlord Tenant
Living Trust
Name Change
Personal Planning
Small Business
Wills & Estates
Packages A-Z
Form Categories
Affidavits
Bankruptcy
Bill of Sale
Corporate - LLC
Divorce
Employment
Identity Theft
Internet Technology
Landlord Tenant
Living Wills
Name Change
Power of Attorney
Real Estate
Small Estates
Wills
All Forms
Forms A-Z
Form Library
Customer Service
Terms of Service
DMCA Policy
About Us
Blog
Affiliates
Contact Us
Privacy Notice
Delete My Account
Site Map
All Forms
Search all Forms
Industries
Forms in Spanish
Localized Forms
Legal Guides
Real Estate Handbook
All Guides
Prepared for You
Notarize
Incorporation services
Our Customers
For Consumers
For Small Business
For Attorneys
Our Sites
US Legal Forms
USLegal
FormsPass
pdfFiller
signNow
airSlate workflows
DocHub
Instapage
Social Media
Call us now toll free:
1-877-389-0141
As seen in:
  • USA Today logo picture
  • CBC News logo picture
  • LA Times logo picture
  • The Washington Post logo picture
  • AP logo picture
  • Forbes logo picture
© Copyright 1997-2025
airSlate Legal Forms, Inc.
3720 Flowood Dr, Flowood, Mississippi 39232