The FDA Drug Approval Process

The FDA Drug Approval Process is a conference dedicated to providing a general introduction to all aspects of the US drug approval process.

The FDA Drug Approval Process covers topics such as:

• 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

The FDA Drug Approval Process brings together attendees with responsibilities in:

• Regulatory affairs
• Preparing US registration documents
• Advising companies on strategies for developing new drugs for the US market

The next FDA Drug Approval Process will be held on 11-12 Mar 2021.