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FDA Releases Final Guidance: Transition of Previously Approved Drugs to Being “Deemed Licensed” Biologics | Wilson Sonsini Goodrich & Rosati – JDSupra

By March 16, 2020No Comments
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U.S. prescription drugs can broadly be divided into two categories: 1) small molecule drugs and 2) biologics. Small molecule drugs tend to be chemically synthesized and often have molecular weights under 1,000 Daltons. Contrastingly, biologic drugs are larger and more complex molecules, for example proteins, viruses, and living cells such as CAR-T cells.

 

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