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Last week, FDA released a draft guidance, “ Labeling for Biosimilar and Interchangeable Biosimilar Products ” (“2023 Draft Guidance”) that—when finalized—will revise and replace its July 2018 final guidance, “ Labeling for Biosimilar Products.”

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Contents

RX Note

G6PD Deficiency - Explaining G6PD Deficiency Ramadan - Medications during Ramadan fasting Adverse Drug Reactions Adverse Drug Reactions - All adverse reactions are adverse drug event Pharmacovigilance - To detect unreported ADRs Drug Allergy - Management vary based on the signs and symptoms Medicine-induced Discolouration - Red?