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Manufacturing regs for INDs

Executive Summary

FDA will issue a guidance and a direct final rule on good manufacturing practices for investigational new drug applications once the White House Office of Management & Budget has completed its review of the rule. The amount of information needed in the GMP filing "depends on the stage" of drug development, FDA said, noting that not all manufacturing work would have to be complete when a product enters Phase I and that early-stage submissions should focus on product identity as it relates to safety. The accompanying guidance will explain "the stepwise approach to meeting current [GMP] regulations"...
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