FDA News: Issue 29, September 2021

Author: [AUTHOR] Published on 9/17/2021 5:00:00 AM

Updated Agenda and Background Materials Now Available for Next Week’s FDA and Duke-Margolis Public Workshop on Pharmacodynamic Biomarkers for Biosimilar Development

Join the Duke-Margolis Center for Health Policy and the US Food and Drug Administration (FDA) for a public workshop titled “Pharmacodynamic (PD) Biomarkers for Biosimilar Development and Approval.” The workshop will feature global perspectives from regulators, biosimilar developers, and academic researchers on the future of PD biomarkers and biosimilar development, the FDA’s initiatives to advance PD biomarkers and biosimilar clinical pharmacology guidance, and ongoing research to advance the broader application of PD biomarkers.

An updated Agenda and a detailed Background document are now available at: https://healthpolicy.duke.edu/events/biosimilar.

The date, time, and location of the workshop are as follows:
Date: September 20 – 21, 2021
Time: 10:00 am – 2:30 pm ET (both dates)
Location: Virtual

Registration: This workshop is open to the public with no cost to attend, but registration is required. To see the agenda and register, please visit: https://healthpolicy.duke.edu/events/biosimilar.

Questions: For questions regarding this event, please send an email to luke.durocher@duke.edu.

The Office of Clinical Pharmacology (OCP) is pleased to offer the e-mail subscription service Clinical Pharmacology Corner. This is a free service from FDA to provide occasional updates from OCP regarding newly approved therapies, new regulatory and scholarly publications, upcoming events and other items of interest. Subscribe today at https://public.govdelivery.com/accounts/USFDA/subscriber/topics and select Clinical Pharmacology Corner under Drugs.

We always welcome your thoughts regarding the format, content, and utility of this communication. Comments may be sent via email to ocp@fda.hhs.gov.

This communication was prepared by Office of Clinical Pharmacology, Office of Translational Sciences, CDER, FDA.

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