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New FDA ANDA Stability Guidance Will Embody ICH Standards; GPhA Supportive With Some Adjustments

Sep 10th, 2012

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The Office of Generic Drugs will be issuing a new draft stability guideline that will more formally align the expectations for Abbreviated New Drug Applications (ANDAs) and Drug Master Files (DMFs) with ICH and a QbD-oriented regulatory paradigm.

In the absence of current formal guidance on its stability expectations, OGD has generally been relying on the ICH Q1 stability standards. However, the lack of clear directions has resulted in the office having to field recurrent inquiries from the generics industry about stability requirements for ANDAs and DMFs.

OGD is now targeting formal adoption of the ICH stability and QbD expectations, reflecting its desire to better align the requirements for generic drugs with those for new drugs and internationally.

At the GPhA/FDA CMC workshop, OGD Senior Review Chemist Raman Murali addressed his office’s stability expectations.  He reviewed: ● the current status ● new expectations ● the draft ANDA stability guidance, and ● ICH Q1 requirements (see box below).

Murali’s talk gives a good indication of what the new guidance will contain and provides a context for the OGD adoption of the ICH standards.

[The story continues for subscribers beginning on page 2, and includes a discussion of adjustments that GPhA is proposing to the draft guidance.  Nonsubscribers can purchase the story for $195 by contacting Wayne Rhodes ([email protected]).  For subscription/license information, click here.]

See related stories:

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

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

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