In Focus: Alternative Approval Pathways for Drug Products

Posted 01 April 2010 | By

Developing new drugs and biologics is a lengthy and expensive process, often costing hundreds of millions of dollars and requiring up to 10 years. However, not all new products require similar investment of resources for approval by the US Food and Drug Administration. There are several regulatory pathways, some new and some that have existed for years, that could lead to regulatory approval in less time and with fewer financial and technical resources. This issue of Regulatory Focus addresses some of these alternative pathways. Although similar development pathways are available in many countries, in the US they are exceptionally advantageous due to a number of regulatory incentives.

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