Changes to OGD’s API DMF Process Target Submission Quality and Review Streamlining

Significant changes are being made by FDA’s Office of Generic Drugs (OGD) to its active ingredient Drug Master File (DMF) review program to improve the quality of industry submissions and streamline the review process so that DMFs are not a rate-limiting factor in ANDA clearance.

Based on a careful assessment of the problems in the current DMF system, OGD has developed a three-pronged approach that entails: ● implementing a Question-based Review (QbR) system for DMFs ● consolidating drug substance review in OGD’s recently-formed DMF Team, and ● instituting “Completeness Assessments” that will determine if sufficient documentation is present in the DMF prior to the full review.

At a CMC workshop co-sponsored by the Generic Pharmaceutical Association (GPhA) and FDA in late May in Bethesda, Maryland, OGD’s DMF Review Team Leader David Skanchy provided an in-depth review of the problems that the three initiatives are intended to address and how they will help solve them (Skanchy’s full remarks are provided below).

He emphasized that the changes OGD is making “are going to be coming at the regulated industry very soon.”  The goal of his presentation, he said, is to increase the attendees’ “comfort level” with the initiatives by describing them in detail and the rationale for putting them in place as well as explaining how the agency and industry can work together to help make their implementation “go smoothly.”

Overhaul of the DMF system is one of several efforts that the office is actively engaged in that will have a significant impact on the future of the generic drug approval process.

Also advancing through the pipeline are initiatives that will: ● harmonize stability requirements with ICH ● streamline agency management of manufacturing change supplements ● create a peptide drug review team ● advance OGD’s quality management system ● organize applicant and ingredient information in knowledge management databases, and ● refine the QbR system for ANDAs.

A key driver for the OGD efforts is the expanded backlog of generics applications and the agreements reached through the user fee negotiations to create a more efficient and effective review process going forward.

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See related IPQ stories:

The Role of QbD in ANDA Review Draws Comment from Generics Office Management

FDA’s Generics Office is Revising its QbR Questions to Sharpen Focus on QbD and Control Strategy

FDA Generic Drugs Office Advances QbD, Review Processes and Quality Management System in Anticipation of User Fees

IPQ Special Report May 2010, pp. 17-19