4.2: Private Sector Development

Accelerate private sector development of new drugs, biologic therapies, and medical technology

Other Information:

How We Will Accomplish Our Objective - Use science-based risk management in all regulatory activities, so that limited resources can provide the most health promotion and protection at the least cost to the public. - Provide timely, high quality, cost-effective processes for review of new technologies/premarket submissions. - Initiate the development of a continuous improvement/quality systems approach to the approval process throughout pre-market review of new applications. - Direct Agency research programs and develop standards to effectively handle emerging technologies, especially in areas of pharmacogenomics, gene therapy, and combination devices. The objective is more efficient and rapid translation of new scientific developments and breakthroughs into safe and effective medical products. - Reduce avoidable delays and costs in product approvals through clear expectations and effective communication of standards to sponsors by: 1) analyzing root causes of multiple review cycles and establishing steps to prevent additional cycles when possible and 2) developing additional Agency guidance on innovative and cross-cutting product development where development pathways are particularly difficult or unclear.

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Indicator:1

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