In a blog post, FDA Commissioner Scott Gottlieb reported on the Spring 2018 Unified Agenda of Federal Regulatory and Deregulatory Actions. The agenda “provides federal agencies with the opportunity to update the American public on our government’s regula- tory priorities,” and includes some of FDA’s major policy goals for 2018, such as proposing: ● a rule that defines biological prod- ucts, and ● a rule that would permit the contained use of DMFs for NDAs subject to the Biologics Price Competition and Innovation (BPCI) Act, which requires biological products approved under NDAs to transition to a BLA by 2020. BLAs generally may not rely on drug substance, intermediate or product information contained in master files.
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