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Generic Industry Has Made Progress Implementing QbD

This article was originally published in The Gold Sheet

Executive Summary

The generic drug industry has progressed swiftly with QbD, reports an FDA OGD official. The share of ANDAs containing QbD elements has tripled from 25% in June 2012 to 83% in January 2013 – while brands struggled to reach 14% QbD last year with their NDA filings.

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Slogging Toward Quality by Design

Ten years into FDA’s quality initiative, CDER Director Janet Woodcock acknowledges continued resistance to investing in QbD as a way of preventing quality problems in commercial manufacturing. Yet others in FDA and industry see adoption of the science- and risk-based approach spreading, even though manufacturers are often reluctant to disclose how much money it’s saving them.

FDA Warns Generics Firms About January QbD Deadline for ANDAs

Come January, if there is no quality target product profile (QTPP) in an abbreviated new drug application (ANDA), FDA might not file it, agency officials told a Generic Pharmaceutical Association workshop. Even though quality by design (QbD) remains optional for brand drugs, it will be expected for generics, said Office of Generic Drugs representatives who went on to outline pending question-based-review (QbR) revisions designed to elicit QbD information.

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