Module 1 2021

Agenda

BACKGROUND • The US Food and Drug Administration (FDA)

TACTICAL CONSIDERATIONS • IND Applications • Marketing Applications

STRATEGIC CONSIDERATIONS • Regulatory mechanisms and special programs • Working with the FDA

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Food and Drug Administration

• United States FDA • Part of US Department of Health & Human Services • FDA commissioner: Dr. Janet Woodcock (Acting since January 2021)

• Website: www.fda.gov

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