The Us Drug Approval Process 2013

The US Drug Approval Process is a conference dedicated to a general important information and introduction on FDA requirements and procedures for marketing authorizations, including:

• General regulatory requirements
• Structure and functions of the FDA Historical background
• New drug application process
• Regulation of preclinical and clinical research
• Generic drugs
• Biologics (including biosimilars)
• Special issues
• OTC drugs

Speaker: Richard Kingham, Partner, Covington & Burling LLP, Washington DC