FDA revises ANDA facility correspondence draft guidance

Regulatory NewsRegulatory News | 02 December 2022 |  By 

The US Food and Drug Administration (FDA) on Friday revised its draft guidance on submitting pre-submission facility correspondence (PFC) for generic drug applicants seeking a priority review of their abbreviated new drug application (ANDA), prior approval supplement (PAS) or an amendment to either submission type in line with the Generic Drug User Fee Amendment (GDUFA III) program.
 
The process can be used by generic drug sponsors to get a priority review goal date for their submission, but the PFC must be submitted two months before they submit their premarket application. The original version of the guidance was published in June 2017 and revised shortly thereafter in November 2017. (RELATED: Priority Generic Drug Reviews: New FDA Draft Guidance, Regulatory Focus 19 June 2017)
 
The new guidance reflects changes to the content, timing and assessment of a PFC within the ANDA program as laid out under GDUFA III. It describes the process generic drug applicants who want priority review should follow to provide complete and accurate facility information before submitting a priority original ANDA, PAS, PAS amendment or ANDA amendment.
 
“As described in the GDUFA III commitment letter applicable to this latest reauthorization, FDA has agreed to performance goals and program enhancements regarding aspects of the generic drug assessment program that build on previous authorizations of GDUFA,” FDA said. “New enhancements to the program are designed to maximize the efficiency and utility of each assessment cycle, with the intent of reducing the number of assessment cycles for ANDAs and facilitating timely access to generic medicines for American patients.”
 
The agency said that a complete PFC submission should include all the information reviewers need to make an informed decision about the need for facility inspections that support their ANDA application. The PFC submission should include the information that FDA needs to assess the facilities involved in manufacturing processes and testing of the drug product, including facilities in corresponding Type II active pharmaceutical ingredient drug master files (API DMFs) referenced in an ANDA and all sites or organizations involved in bioavailability/bioequivalence analytical and clinical studies used to support an ANDA.
 
“A complete and accurate PFC should provide the information necessary for FDA to determine each facility’s manufacturing operation capabilities for drug product or API, and to identify the need for a (preapproval inspection),” said FDA. “This information should include a description of the manufacturing process, controls of critical steps, and anticipated differences between pilot/exhibit scale and commercial scale processes. Information regarding the conformance of exhibit batches to specifications should be provided.”
 
For each manufacturing facility, the applicant is also asked to include the facility name, operations performed, facility contact name, address, FDA Establishment Identifier (FEI) number (if a required registrant or one has been assigned), DUNS number, registration information (for required registrants), confirmation that the facility is ready for inspection and certification that any Type II DMF has similarly complete and accurate facility information.
 
FDA emphasized that PFC applications must be submitted using the electronic common technical document (eCTD) format at least 60 days before an ANDA is submitted to the agency for review.
 
“In general, under the terms of the GDUFA III commitment letter, if the PFC is found to be incomplete or inaccurate, or there are significant changes to information contained in a PFC when submitted in the ANDA, or if information received in a final bioequivalence study report included in the ANDA leads FDA to a decision that an inspection is necessary, the 10-month standard review goal will generally apply instead of the priority review goal electronic common technical document (eCTD) format,” the agency cautioned.
 
The draft guidance lists the facility information FDA wants from sponsors if they have clinical bioequivalence study sites and analytical bioequivalence sites and includes a Q&A section that addresses common questions about the PFC application. It also contains a glossary of commonly used terms to ensure regulators and sponsors are on the same page over terminology.
 
Stakeholders interesting in commenting on the new draft guidance can do so until 5 March 2023, on www.regulations.gov under docket no. FDA-2017-D-3101.
 
FDA

 

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