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  1. Generic Drug User Fee Amendments

GDUFA III Changes for Facilities

FDA has completed several commitments under the terms of the Generic Drug User Fee Amendments of 2017 (GDUFA II) commitment letter to provide greater transparency regarding prioritization and scheduling of facility inspections, as well as to communicate information following inspections. These efforts include updating FDA’s publicly available Inspection Classification Database, communicating with foreign regulatory authorities regarding the compliance status of establishments, providing information on the Agency’s risk-based site selection model, and communicating information from inspections that might affect approvability to applicants and facility owners.   

The performance goals and program enhancements specified in the terms of the GDUFA Reauthorization Performance Goals and Program Enhancements Fiscal Years 2023-2027 (GDUFA III) commitment letter apply to aspects of the generic drug assessment program and build upon the GDUFA program established and enhanced through previous authorizations.  

  1. Foreign Regulators 
  2. Communications Regarding Inspections
  3. GDUFA III Inspection Classification Database
  4. Post-Warning Letter Meetings 
  5. Generic Drug Manufacturing Facility Reinspection

Foreign Regulators

FDA will support the export of safe and effective pharmaceutical products by the U.S.-based pharmaceutical industry, including but not limited to providing timely updates to FDA’s Inspection Classification Database, and educating other health authorities regarding FDA’s surveillance inspection program and the meaning of inspection classifications.

Upon receipt of a written or email request by an establishment physically located in the United States that has been included as part of a marketing application submitted to a foreign regulator, issue within 30 days of the date of receipt of the request a written communication to that foreign regulator conveying the current compliance status for the establishment.

Post-Warning Letter Meeting and Generic Drug Facility Reinspection

After an inspection, if FDA classifies a generic drug manufacturing facility as official action indicated (OAI), the compliance status for that facility’s firm with current good manufacturing practice (CGMP) regulations is considered unacceptable.

Certain firms that have been classified as OAI as a result of an inspection may be eligible to request a post-warning letter meeting or reinspection. In a post-warning letter meeting, FDA provides preliminary feedback on the adequacy and completeness of the facility’s corrective action plans.

To be eligible to request a post-warning letter meeting or reinspection under the terms of the GDUFA III commitment letter, facilities must meet all of the following criteria: 

  1. The facility CGMP compliance status is OAI as a result of an FDA inspection.
  2. The facility has paid a GDUFA facility fee as described in section 744B(a)(4) of the Federal Food Drug and Cosmetic (FD&C) Act for the current fiscal year or is named in a pending abbreviated new drug application (ANDA).
  3. The regulatory action (e.g., warning letter) is limited only to violations or deviations from Section 501 of the FD&C Act (21 U.S.C. 351) related to human drug manufacturing, including manufacturing of a drug-device combination product.

Requests should be sent to
FDA-GDUFAIII-PostWarningLetterandReinspectionRequests@fda.hhs.gov and include: 1) a list of all corrective and preventative actions (CAPAs) undertaken in response to the inspection and resulting warning letter, and 2) their current CAPA remediation status as of the date of the meeting request.

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