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Channel: Gilbert “Chip” W. Carnathan – IMPACT Pharmaceutical Services, Inc.
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Formal Meetings with FDA for Biosimilar Products

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February 10, 2016 | Chip Carnathan, PhD, RAC, Director Regulatory Affairs | Regulatory Affairs, Drug Development Consulting Yeah, yeah, we know. The general public considers biosimilars to be “generic” versions of approved biological products. The FDA has gone to great lengths to disavow us of this perception because, as we have discussed before, there cannot […]

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