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
