“Deemed to be a License” Guidance from FDA

Overview


Kristin Connarn wrote this bylined article on draft FDA guidance covering how certain products that the FDA has historically regulated as drugs will transition into biologics in March 2020. Ms. Connarn wrote that the draft guidance provides important information on preparing for the 2020 transition, including what happens to approved and pending applications for transitional products and how the transition will affect exclusivity.

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