This article was originally published in The Gold Sheet
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Regulators in the U.S. and Europe are a little closer to harmonizing their reviews of new drug applications containing QbD elements under a joint review program. Areas of agreement include what is meant by QTPP and criticality, while areas of disagreement include NIR methods and design space development.
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.
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.