US FDA Ready To Move Forward On Developing Quality Management Maturity Rating System
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.
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Healthcare Distribution Alliance CEO Chip Davis says drug wholesalers and suppliers need the government’s information on product demand, just as the government needs industry inventory data, to anticipate and avert shortages.
CMC And GMP Updates In Brief: Continuous Manufacturing, Accelerated CMC Reviews
ICH general assembly adopts guidelines on continuous manufacturing and risk management; US FDA opens pilot project to expedite CMC reviews for products with accelerated review timelines; other recent topics include quality maturity inspections and compounding standards.