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FDA FIELD OFFICES TO INCREASE AUDITS OF NDA, ANDA APPLICATIONS -- REGIONAL DIRECTOR TELLS RAPS; GREATER EMPHASIS ON "SCREENING" INSPECTIONS NOTED

Executive Summary

FDA field investigators will be stepping up audit activities of NDA and ANDA applications, FDA Mid-Atlantic Regional Director Richard Davis told a Sept. 20 meeting of the Regulatory Affairs Professionals Society (RAPS) in Alexandria, Virginia. Addressing changes in agency inspection activities in the wake of the generic investigations, Davis said that "you can all expect that there will be a great deal more done in the area of audit inspections -- audits of the applications that are being filed by the industry with the agency." Davis explained that the field offices will be in close contact with FDA headquarters to monitor application filings. While the manufacturing and testing data in the applications is under headquarters review, he said, "we are also going to be looking at how that data was developed and looking at the good manufacturing practices associated with those products." Davis noted that the audit inspections could be initiated at the request of a manufacturer seeking early agency input in the clearance process. Audit inspections could also occur, he pointed out, when a reviewer has specific concerns about an application or when the filing company has had GMP or quality control problems involving related products. Davis suggested that companies communicate early with the agency about upcoming applications involving new chemical entities, new processes or new plants. He said that this will allow the field to work with the applicant to assure a smooth review. On the other hand, where the agency has concerns about GMP or quality control problems, such as a recall involving products or processes similar to that in the application, Davis warned: "We will certainly not issue approval until those situations are corrected and solved." Another inspection approach that FDA will be focusing on in the coming year, Davis said, is a "screening inspection." This type of inspection will be conducted by the agency in order to target a specific industry problem area that has come to the agency's attention or that the agency may want to gather further information about. Davis cited labeling mix-ups as an example. As a result of the increase in "screening" inspections, Davis said, firms "may see an investigator more times than in the past." However, he added, "hopefully these screening inspections will not take as long as some of the other broader inspections would." Davis also advised manufacturers to expect increased agency sampling over the next year as a result of an improvement in FDA's analyzing capabilities. The regional director noted that his region's Cincinnati laboratory has recently completed a major overhaul involving full computer automation and robotics. Drug analysis will be consolidated in this "highly efficient" lab, Davis explained, allowing for a significant expansion in the number of drug samples that the agency can process. The region's Baltimore Lab, in turn, has also been upgraded and will specialize in research and methods analysis and in specialized analytical areas such as biotechnology. The three regional directors addressing the RAPS meeting all noted that firms can expect to find FDA investigators frequently accompanied by those from the HHS Inspector General's (IG) office. FDA Mid-Western Regional Director Burton Love cautioned manufacturers from drawing any immediate conclusions about the IG appearance, noting that the inspection could involve either a routine inquiry at the firm or a monitoring of FDA's own inspection process. Davis, in turn, downplayed the importance of the FDA/IG joint investigation process, commenting that the agency has routinely worked with the IG as well as a variety of other federal and state authorities in carrying out its field monitoring efforts.

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