PharmiWeb.com - Global Pharma News & Resources
21-Mar-2019 - 22-Mar-2019

The FDA Drug Approval Process

  • Location:
    • Venue to be confirmed

General introduction and important information on FDAProcedures requirements for marketing authorizations and recent developments affecting the drug approval process in the US

Course overview

This seminar, by a US lawyer with over 40 years of experience dealing with pharmaceutical regulation in the United States and Europe, will provide a general introduction to all aspects of the US drug approval process. It will also cover the organisation and structure of the Food and Drug Administration, recent amendments to the FDA’s procedures designed to expedite the testing and approval of new medicines and other topics of current interest.