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Clinical Pharmacology by ClinicalKey

RX Note

Introduction Clinical Pharmacology powered by ClinicalKey provides current, dependable drug information, including off-label indications, to guide treatment recommendations. Drug Class Overviews Provides information on therapeutic use, comparative efficacy, adverse reactions and drug interactions.

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FDA Releases Draft Labeling Guidance for Biosimilar Products

Big Molecule Watch

Last week, FDA released a draft guidance, “ Labeling for Biosimilar and Interchangeable Biosimilar Products ” (“2023 Draft Guidance”) that—when finalized—will revise and replace its July 2018 final guidance, “ Labeling for Biosimilar Products.”