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FDA’s Center for Veterinary Medicine Using QbR and Other CDER-Tested Approaches to Decrease Review Times; CVM User Fees Drive Guidance Development

The use by FDA’s Center for Veterinary Medicine (CVM) of a question-based review (QbR) approach in CMC submissions over the past three years has resulted in significantly decreased review times for both new and abbreviated new animal drug applications (NADAs and ANADAs) for multiple dosage forms, including sterile products – in many cases with the reviews accomplished in a single cycle....

Continuous Manufacturing does not Present Regulatory Hurdles, FDA Experts Say

The regulatory definitions of “batch” and “lot” do not present hurdles for implementing continuous manufacturing, FDA is stressing in highlighting the potential the new processing approaches offer to advance the objectives of its 21st Century quality initiative....

Quality System Adjustments Needed for Continuous Manufacturing

The quality system adjustments needed to accommodate continuous manufacturing are getting attention at regulator/industry forums where the dialogue on how to drive forward the new processing technologies is underway....

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CLICK HERE  for the IPQ Monthly Update – September/October 2020 in Review


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