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Blog Post

FDA Guidance on Transition Biological Products: Implications for Exclusivity and Patent Listings

FDA issued a draft guidance on March 14, 2016 explaining how the agency proposes to implement the provisions under the Biologics Price Competition and Innovation Act of 2009 (BPCIA) for...

Blog Post

Biosimilars: Who’s Who at FDA?

According to several recent presentations by U.S. Food and Drug Administration (FDA) officials, the agency has established three committees charged with discussing and coordinating issues...

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