Question-based Review (QbR) is a format proposed by United States Food and Drug Administration (US FDA) enhancing the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use's Common Technical Document (ICH CTD) format to streamline the submission process. ...
(ANDAs),orTypeIIDMFsubmissionsthat followaQuestion-basedReview(QbR)formatinconjunctionwiththeInternational ConferenceonHarmonisation(ICH)guidanceM4Q:TheCTD–Quality,(ICH M4Q)Module2. •TheMAPPmayalsobeusedasaguidefortheassessmentofsubmissionsthatdonot followtheQbRformat. BACKGROUND •QbRwasdevelopedforthe...
CTD electronic format recommended for ANDAs to support QBR.(Question-based review)Pickett, Joseph