WSGR: Effective Regulatory Strategies: Tapping into FDA Expedited Review Pr...

Speaker:

Charles Andres, J.D., Ph.D., RAC
Patent & Innovation Strategies and FDA/Life Sciences Groups
Wilson Sonsini Goodrich & Rosati, P.C.

"Effective Regulatory Strategies: Tapping into FDA Expedited Review Programs"

Effective regulatory strategies are important success drivers for drug and medical device companies. They have several components and:

• Sync seamlessly and synergistically with patent strategies;
• Realize all available U.S. Food and Drug Administration (FDA) regulatory exclusivities;
• Play a significant role in maximizing product life span (as part of lifecycle management);
• Minimize costs, resources, and time devoted to clinical development; and
• Shorten FDA review times and result in successful FDA clearance or allowance.

The talk will provide an introduction to four important FDA programs that are designed to help expedite drug and medical device development and market entry. These programs should always be evaluated when designing effective regulatory strategies.