Countdown To Transition: US FDA Says 91 Drugs Will Become Biologics In March 2020
Countdown To Transition: US FDA Says 91 Drugs Will Become Biologics In March 2020
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A Pink Sheet infographic shows how insulins account for the largest category of transition products, with 27 NDAs that will be deemed BLAs in six months as the FDA is addressing the transition of authorized generic insulins to regulation under the PHS act.
Author: Informa Pharma Intelligence
Publisher: Pinksheet
- Description
In September the US Food and Drug Administration issued an updated preliminary list of 91 new drug applications approved under the Food, Drug and Cosmetic Act that will become “deemed” biologics license applications regulated under the Public Health Service on 23 March 2020 when the Biologics Price Competition and Innovation Act’s transition provisions take effect. A Pink Sheet infographic shows how insulins account for the largest group of products affected by the transition and Pink Sheet shares details on the products in question by category including whether they were active or discontinued.
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