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Event Details


The FDA Drug Approval Process

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Who should attend?

This meeting will be especially helpful for persons responsible for preparing US registration documents (INDs, NDAs, biologics licence applications, etc), regulatory affairs personnel, lawyers and others responsible for advising companies on strategies for developing new drugs for the US market. The seminar will emphasise issues of interest to innovative manufacturers, but will also deal with issues relating to generic drugs and over-the-counter drugs.


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.




Leigh White

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