Advancing the Use of Biomarkers and Pharmacogenomics; Notice of Public Meeting; Request for Comments

The Food and Drug Administration (FDA or the Agency) is announcing a public meeting to discuss current scientific and regulatory approaches to biomarker development, acceptance, and utility in drug and biologic (hereafter referred to as therapeutic product) development programs. The purpose of the public meeting is to initiate constructive discussion and information sharing on the advancement of biomarker science in the context of therapeutic product development among relevant stakeholders.


September 5, 2014


9 am to 5 pm


Washington Plaza Hotel, 10 Thomas Circle NW., Washington, DC 20005. For additional travel and hotel information, please refer to Advancing the Use of Biomarkers and Pharmacogenomics in Drug Developmentdisclaimer icon.


The meeting venue has limited seating. Individuals who wish to attend the public meeting must register on or before August 5, 2014, by visiting PDUFA Public Meeting: Biomarkers and Pharmacogenomicsdisclaimer icon. Early registration is recommended. When registering, please provide the following information: Name, title, company or organization (if applicable), postal address, telephone number, and email address. Registration is free and will be on a first-come, firstserved basis. However, Brookings may limit the number of participants from each organization based on space limitations. Onsite registration on the day of the meeting by Brookings will be based on space availability. If you need special accommodations because of disability, please contact Joanna Klatzman at the Brookings Institution (email: jklatzman@brookings.edu) at least 7 days before the meeting.


Padmaja Mummaneni, Food and Drug Administration, Center for Drug Evaluation and Research, 10903 New Hampshire Ave., Bldg. 51, Rm. 2164, Silver Spring, MD 20993, 301–796–2027, email: padmaja.mummaneni@fda.hhs.gov; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993, 240–402–7911, email: stephen.ripley@fda.hhs.gov.


Page Last Updated: 09/15/2014
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