Expediated pathways, designed to provide drugs to patients sooner, are being used more often.  These “express lanes” are open to products containing both significant benefit over available therapies and filling an unmet need.

This presentation will examine the opportunities and incentives available to sponsors to expedite the development and approval of drugs and biologics, with a focus on the United States.

The topics covered will include:

• FDA programs to accelerate development and approval of drugs and biologics for serious and unmet need
• Approval statistics for expedited programs
• Priority Review Vouchers – history and use
• Exclusivity incentives

To register or to find more information click below.

RAPS Members have complimentary registration. Non-member registration is $20.