Pharmaceutical Compliance Monitor
The help to keep in Compliance
The recently released draft guidance on biosimilar development by the U.S. Food and Drug Administration (FDA) signaled a major and long overdue step in establishing a formal regulatory structure for these products in the United States. There remains, however, much work to be done. The new guidance, which lays out FDA expectations for biosimilars, may remove some of the uncertainties manufacturers had before, but many lingering questions remain.
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Last month, the Food and Drug Administration issued draft Guidances pursuant to its authority under the Biologics Price Competition and Innovation Act of 2009. The draft Guidances are intended by the agency to implement the follow-on biologic drug pathway mandated by the statute, and are set forth in three separate Guidances directed to:
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On February 9, 2012, the FDA issued long-awaited (draft) guidance documents on biosimilars. The three guidance documents address scientific considerations, quality considerations, and implementation of the Biologics Price Competition and Innovation Act of 2009, with a focus on therapeutic protein products. As set forth in the FDA news release, the FDA will seek public comments on the guidance documents (details on how to submit comments will be announced in an upcoming Federal Register Notice).
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