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FDA is Working to Expand Question-Based Review Approach From Generic to Innovator Applications

Jul 2nd, 2013

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A working group that spans the new drug and generic reviewing offices at FDA’s Center for Drug Evaluation and Research (CDER) is nearing release of a proposed revision of the questions it developed under its question-based review (QbR) approach for generics that is designed to be applied to innovator applications as well.

CDER will continue explaining the QbR revision to and seeking input from both the brand and generics sectors of the industry through face-to-face meetings, workshops and conferences, and will be piloting the revised questions in the latter part of 2013.  Finalization of the revised QbR is expected by the end of the year.

The initiative has potentially far-reaching implications, and could open avenues for refining the ICH CTD model internationally and arriving at a more process-improvement-friendly and harmonized CMC submission paradigm.

A year ago, OGD released a preliminary draft intended to sharpen the focus of the QbR questions on the quality-by-design (QbD) and control strategy information the office wants industry to provide in Abbreviated New Drug Applications (ANDAs) (IPQ “The News in Depth” August 22, 2012).

However, the revision initiative became woven into an effort getting increasing emphasis at CDER to harmonize approaches to ensuring drug product quality across its portfolio of branded, generic and over-the-counter products – an effort the Office of Pharmaceutical Quality would be set up to foster (IPQ “The News in Depth” April 25, 2013).

The membership of the QbR working group, originally drawn only from OGD, now includes Office of New Drug Quality Assessment (ONDQA) staff as well.  The team has made refinements to the earlier proposal to make sure that it would be applicable beyond generic drugs.

A report on the progress the working group has been making on its QbR initiative was presented by OGD Reviewer Jennifer Maguire at a CMC workshop cosponsored by the Generic Pharmaceutical Association (GPhA) and FDA in Bethesda, Maryland in early June.

She characterized the working group effort as “extremely collaborative.”  The group has found that “the areas of commonality” in the submission expectations for NDAs and ANDAs “far outweigh those of dissimilarity.”

In her presentation, Maguire provided insights into the changes the team is making to the review questions and explained the motivation for the rewording and additions as well as what specifically her office would be looking for in the company responses to them.

[The story continues for subscribers beginning on page 2.  Included is a color-coded list of the QbR questions that highlights what changes are being considered from the previous revision.  Nonsubscribers can purchase the story for $195 by contacting Wayne Rhodes ([email protected]).  For subscription/license information, click here.]

See related IPQ stories:

FDA’s Center for Drugs Redoubles Effort to Achieve 21st Century Quality Vision and Foster Continuous Process Improvement

FDA Seeking Industry Input on Quality Metrics to Help Rationalize Its Review and Inspection System

FDASIA Implementation and a Sharpened Focus on Quality Head Center for Drugs’ Agenda

FDA’s Draft ANDA Stability Guidance Applies ICH Expectations to Generics

GPhA Weighs In On API and QbD Issues Needing Clarification for Generics; OGD Outlines Starting Material Expectations

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

Initiatives to Strengthen FDA’s Generic Drug Review Process Include OGD Supplement and Peptide Teams

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

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

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