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Home » FDA Alerts Compounders to Changes Resulting From NDA to BLA Transition
FDA Alerts Compounders to Changes Resulting From NDA to BLA Transition
The FDA said it does not plan to take enforcement action, under certain conditions, against outsourcing facilities that use four bulk drug substances that will no longer be eligible for mixing, diluting or repackaging following the agency’s transition of nearly 100 biological products from NDAs to BLAs on March 23.