1.1: New Technologies/Premarket Submissions

Provide timely, high quality, cost-effective process for review of new technologies/premarket submissions.

Other Information:

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 guidances on innovative and crosscutting product development where development pathways are particularly difficult or unclear. Initiate the development of a continuous improvement/quality systems approach to the approval process throughout premarket 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. Highlights for Objective 1 Improving the process for developing new medical technologies is an FDA priority. New technology development presents uncertainties that increase business risks and costs and sometimes create barriers to innovation. These factors can contribute to keeping important new medical products from people that need them and cause the public to miss out on the realization of certain public health benefits of new technology. National Cancer Institute (NCI) – In May 2003, the FDA and NCI formed a joint task force to address opportunities for improving the development of new cancer therapies. This effort will include sponsoring workshops and collaborative discussions with stakeholders regarding appropriate clinical trial design for cancer therapies by type of cancer and stage of disease. Continuous Marketing Application (CMA) – The first CMA pilot (a PDUFA initiative) will provide early review of relevant portions (reviewable units) of a sponsor's new drug or biologic product application submitted in advance of the complete application. The goal is to improve the quality of the information that the agency receives during the first review cycle and avoid the need for multiple-cycle reviews.

Indicator(s):

Indicator:1

Content