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The Monthly Update for September is Now Available

Sep 21st, 2012

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The September Monthly Update takes a deep dive into FDA’s broad-ranging efforts to create a more efficient and effective generic drug review process, supported by QbD and user fees, that can address an expanded backlog of ANDAs and fulfill its GDUFA commitments to industry.

The first story in the series focuses on the revision the generics office is making to the questions underpinning its Question-based Review (QbR) approach to sharpen their focus on the QbD and control strategy information the office wants industry to provide.

The QbR upgrade represents a considerable effort by OGD to find a pragmatic approach to implementing QbD and releasing its potential to facilitate the drug development and approval process. The second story explores OGD management’s view of QbD’s potential, and, more broadly, how and where it will impact the generics regulatory process.

The IPQ Update then focuses on two other major focal points of the OGD effort: DMFs and stability.

The improvements being made to the DMF component of the generic drug review process include: ● the extension to DMFs of the question-based review approach successfully applied to ANDAs ● the creation of a DMF team to oversee the drug substance filings across applications, and ● completeness assessments that will determine which applications can move forward into the review queue.

The stability initiative reflects OGD’s desire to better align the requirements for generic drugs with those for new therapeutics and internationally.  OGD will be issuing a new draft stability guidance that will incorporate the ICH guidelines and a QbD-oriented regulatory paradigm.  The IPQ coverage includes recommendations from GPhA member company experts on applying the ICH standards.

The September Monthly then explores other of the many facets of the OGD review process upgrade – from the creation of teams dedicated to reviewing supplements and peptide drugs and exploring where policy and resource improvements are needed, to managers that will shepherd applications through the multidisciplinary obstacles, to better CMC databases on ingredients.

Also covered is input from GPhA’s DMF and QbD subcommittees on the OGD initiatives and where the industry experts feel that further clarification is needed.  One of these areas is starting materials and the story includes a review by an OGD DMF team member on the agency’s current expectations.

The last in the generics series focuses on the new head of the generics office, Gregory Geba, and CDER organizational changes that are being proposed that may result in raising of the office in the center hierarchy.

While the flurry of activity going on in the FDA generic drug review context is the main focus of the September Monthly, the issue also includes coverage of a shot across the bow from a veteran pharma exec on the pressing need for an overhaul of the current industry approach to supply chain outsourcing and customer service to address the disruptions causing drug shortages and pharma’s credibility problems.

To access the Monthly Update, click here.

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