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  1. Generic Drug User Fee Amendments

GDUFA II Facilities Enhancements

 FDA has completed several commitments under the Generic Drug User Fee Amendments of 2017 (GDUFA II) program, to provide greater transparency regarding prioritization and scheduling of inspections, as well as to communicate information following inspections. These efforts include updating FDA’s publicly available inspection classifications 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 may impact approvability to applicants and facility owners.   

  • The inspection classifications database provides the most recent classifications based on FDA’s final assessments following an inspection of manufacturing facilities for routine surveillance purposes or sites conducting bioequivalence/bioavailability studies. FDA updates the database every 30 days. Previously, the agency updated the database every 180 days and did not include inspection classifications of sites conducting clinical bioequivalence/bioavailability studies. The Agency also updated the database to build on our progress implementing the Mutual Recognition Agreement with the European Union, and it now supports inclusion of facility status based on classification of inspection reports from foreign regulatory authorities. 

    Under GDUFA II, FDA committed to updating the inspection classifications database by January 1, 2019 and to continue to update it every 30 days. Due to the interest in making this information available to drug manufacturers, applicants, foreign regulators, and the public, FDA worked diligently to complete the commitment in advance of that goal.  Moreover, FDA’s Office of Regulatory Affairs worked with the Agency’s product centers to go beyond the commitment by including available information and updating the database every 30 days for inspections of all FDA-regulated medical products.
  • The inspection classifications database also partially meets a GDUFA II commitment regarding communications with foreign regulators. Currently, foreign regulatory authorities may contact FDA for information regarding a facility physically located in the U.S. prior to that facility being allowed to export a product to that country. Under GDUFA II, FDA has committed to respond to such requests within 30 days. The Agency has now formally implemented procedures to meet this commitment, but the database will also facilitate foreign regulators’ ability to check the most recent inspection classification on their own.  
  • FDA  has also published a Manual of Policies and Procedures (MAPP 5014.1), Understanding CDER’s Risk-Based Site Selection Model. Under GDUFA II, FDA committed to explaining the Agency’s risk-based site selection model for human pharmaceutical manufacturing establishments. This publicly available MAPP outlines the policies and procedures for the Site Selection Model (SSM) used by CDER staff to prioritize manufacturing sites for routine current good manufacturing practice (CGMP) surveillance inspections. The MAPP outlines the risk factors that are considered for sites included in the SSM as well as the process for continual improvement of the model. 
  • FDA has also implemented commitments concerning communication of facility inspection information to facility owners. Last year, the Agency instituted a Concept of Operations agreement and began issuing letters to communicate inspection classification information to facility owners within 90 days of the close of a surveillance inspection. FDA is now consistently issuing these letters for surveillance inspections of non-compounding drug facilities. In addition, FDA has established procedures so that when application-related inspections (i.e., pre-approval inspections) of facilities or sites associated with Abbreviated New Drug Applications, Prior Approval Supplements, or Type II Drug Master Files result in identification of issues that could impact approvability of the application or supplement, the Agency will notify the applicant through an information request, discipline review letter, or complete response letter. 

Completing these commitments provides industry and stakeholders with more transparent and timely information regarding inspections, which can help companies make more informed marketplace choices as well as more quickly resolve issues that could impact application approvals.


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