The FDA (Food and Drug Administration) Drug Approval Process is a conference dedicated to providing a general introduction to all aspects of the US drug approval process.
Topics
Historical background
Structure and functions of the FDA
Regulation of preclinical and clinical research
General regulatory requirements
Biologics (including biosimilars)
New drug application process
OTC drugs
Generic drugs
Special issues
Who should Attend
Attendees with responsibilities in:
Regulatory affairs
Preparing US registration documents
Advising companies on strategies for developing new drugs for the US market
