Zdrowie i gospodarka · 02/03/2023

FDA Releases Draft Guidance for Potency Assay Considerations for Monoclonal Antibodies and Other Therapeutic Proteins Targeting Viral Pathogens

The US Food and Drug Administration (FDA) has published a draft guidance document to help drug developers ensure the potency of monoclonal antibodies and other therapeutic proteins targeting viral pathogens, with the aim of maintaining consistency and efficacy throughout the product's life cycle.