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FDA INCREASING FIELD OFFICE INVOLVEMENT IN NDA/ANDA APPROVALS

Executive Summary

FDA INCREASING FIELD OFFICE INVOLVEMENT IN NDA/ANDA APPROVALS under a recent inspection program initiated in the wake of the generic scandal. FDA Atlanta District Office Director John Turner told a University of Georgia conference on good manufacturing practices in Athens, Georgia on March 19 that the policy initiative is part of FDA's overall effort stemming from the generics crisis to conduct "more frequent and intensive pre-approval and post-approval inspections" and "to eliminate a reliance on the honor system." * A formal policy directive detailing the FDA compliance office's response to the generics findings is now undergoing agency management review and is expected to be released by this fall. The compliance program will spell out, for example, which types of generic drug applications should receive special pre-approval inspection attention. First-time approvals and ANDA applications involving narrow therapeutic range and hard-to-copy products are being considered by FDA as appropriate candidates for pre-approval inspections. Under the new policy initiative, Turner explained, FDA drug evaluation staff will either specifically request an inspection or will notify the "home" district of the manufacturer when an application reaches the "approvable" stage. The field office will then "be requested to concur on the approval," based on an assessment of that firm's compliance status, he said. If the district office is not aware of any adverse information about the firm's manufacturing compliance status, the field office will recommend that the application be approved, Turner noted. On the other hand, the district may recommend withholding approval when it has information about "significant" GMP compliance problems. Among problems that will be considered significant, Turner said, are lack of process validation for the drug in the application, problems with bio batch size or bioavailability testing procedures, scale-up concerns, and lack of control of records or justification for the process. A third possible response from the district office, Turner said, is a request that the approval be delayed until an inspection can be completed. "Usually this will occur when there is a request for approval and there is not sufficient information available at the district office, and an inspection will be initiated for purposes of attaining that information," Turner explained. The FDAer said he met with his Atlanta field staff on March 19 to discuss the new compliance initiative. Also attending the meeting from Parklawn were FDA Office of Compliance Director Daniel Michels and staffer Paul Vogel. In addition, mid-Atlantic region investigator Henry Avallone was invited to explain how the initiative is being implemented in his region.
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