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FDA Seeing Wide Variation in Drug Application Manufacturing Submissions, Causing Approval Delays

Jul 6th, 2010

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Manufacturing information that is inaccurate, incomplete, inconsistent, or in the wrong section in new and abbreviated new drug applications (NDAs/ANDAs) as well as facilities not being ready for an inspection continue to be problem areas causing delays in application approvals, Center for Drug Evaluation and Research (CDER) officials are reporting.

Speaking at DIA’s Annual Meeting in mid-June, CDER Office of New Drug Quality Assessment (ONDQA) Associate Director for Regulatory Affairs Michael Folkendt noted that his office has seen “wide variation on where and how the manufacturing information is submitted in the drug application, which results sometimes in a delay in initiating the inspection process or not finding a facility until late in the review cycle.”

The CDER review official outlined deficiencies his office has noted that resulted in approval delays and provided suggestions on how and where to present the requested information to smooth the approval process.

Noting that some information is redundant between the Module 3 sections of the NDA and the FDA form 356H, the Folkendt highlighted the importance of putting that information in both places.

“I want to emphasize that in addition to each of the relevant Module 3 sections, we ask that you list all of the manufacturing facilities in the application as an attachment to FDA form 356H.”  He added, “if you are submitting an electronic submission, which is absolutely fantastic for us, put it in Module 1 right behind the 356H form.”

More advice from FDA’s Folkendt on avoiding CMC application delays is provided for subscribers on page 2.

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