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The FDA Drug Development Process

Date: June 4, 2009

9:00 — 11:30am


Ohlone College
Newark Center Campus, Room 1100
39399 Cherry Street
Newark, CA

Sponsor: Ohlone College
Event details:

This presentation provides an FDA perspective of the Drug Development Process. Topics to be covered include: the laws under which the FDA operates; the mission of the Center for Drug Evaluation and Research; legal definition of a drug; preclinical research; three phases of clinical trials; drug applications process; drug review process; role of advisory committees; generic drug review process; orphan drug products; OTC drug process; drug safety/post-marketing safety issues; Adverse Event Reporting; drug advertising; risk communication; Critical Path Initiative; and personalized medicine.

The instructor:
Janet McDonald, PhD, has been a Senior Public Affairs Specialist with the San Francisco District of the US Food and Drug Administration since 1986.  In her capacity as Public Affairs Specialist, she serves ad the first line of communications between FDA and the general public, including the media.  Her principle responsibilituy is public education in all matters pertaining the FDA. Janet has a PhD degree in Nutritional Sciences from the University of California at Berkeley.

Additional information and/or registration:

Registration required. For additional information and registration, click here.

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