NDAs, BLAs To Start Getting KASA Quality Risk Assessments After Successful Pilot With ANDAs
Internal review system reduces US FDA’s administrative work for OPQ risk assessments; agency’s standards will not change, and sponsors will not need to modify applications. Advisory committee endorses expansion, which will roll out to different application types over several years.
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The US FDA will begin work on operationalizing a Quality Management Maturity rating system following a public vote of confidence from its outside advisory committee. There are plenty of key details still to be worked out.
Lift the burden of paper on drug quality reviews and the pace of innovation is no longer a problem for structural engineers or couriers – or even print or electronic document rooms. The focus at the US FDA is now on enabling direct transmission and analysis of critical quality data.
Testing and implementing a more structured, computer-aided assessment process for abbreviated new drug applications (ANDAs) will enable the US Food and Drug Administration (FDA) to accelerate approvals on their first review cycle, according to Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER).