FDA aims for greater use of remote assessments for low-risk facilities

The US Food and Drug Administration (FDA) has conducted more than 20 remote regulatory assessments (RRAs) of manufacturing facilities through its preapproval inspection (PAI) program and hopes to use this remote method more for assessing low-risk facilities, said Derek Smith, deputy director of the Office of Pharmaceutical Manufacturing Assessment (OPMA) in the Office of Pharmaceutical Quality (OPQ) at the 11 April Generic Drug Forum (GDF), which was held virtually and onsite in Bethesda, MD.

Smith and Rakhi Shah, associate director of OPMA, addressed some triggers for PAIs as well as Generic Drug User Fee Amendments (GDUFA III) commitments related to facility evaluations.

Smith said that FDA uses a variety of risk factors to decide whether to conduct an onsite inspection or an RRA. These factors include the firm’s compliance history, manufacturing process risks, the firm’s manufacturing experience, and the number of field alert reports (FARs), recalls and complaints associated with the firms. An onsite PAI will generally be recommended for those sites that have a higher risk score.

Smith said that FDA plans to increase the use of this auditing method for low-risk facilities. Most of these remote assessments have led to approval recommendations, said Smith. “We are hoping that we are mitigating the need to do onsite inspections where feasible and where there is lower risk to conserve the agency’s resources.”

Smith said that manufacturers should treat record requests the same as responding to requests during inspections; they should provide clear and accurate records and explain the context of these records to the agency. He added that firms should ask clarifying questions to ensure the response addresses the request and ensure that contract manufacturing organizations (CMOs) are prepared for pre-approval records requests.

FDA began conducting remote regulatory assessments during the COVID-19 pandemic and has continued using this method as an alternative oversight tool ever since.

Review enhancements discussions

Shah addressed some of the new enhancement made to the generic drug review program under GDUFA III; one of these enhancements was a new pre-submission facility correspondence (PFC) program for generic drug applicants seeking a priority review of their abbreviated new drug applications (ANDA), prior approval supplements (PAS) or an amendment to either submission type. (RELATED: FDA revises ANDA facility correspondence draft guidance, Regulatory Focus 2 December 2022)

She said that to ensure a successful review, sponsors should submit the PFC electronically in eCTD format, certify that all information is complete and accurate, confirm that all facilities are ready for inspection, and notify FDA of any significant changes during the ANDA submission.

Generic Drug Forum

FDA aims for greater use of remote assessments for low-risk facilities

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