FDA Critical Path Initiatives: Opportunities for Generic Drug Development

  title={FDA Critical Path Initiatives: Opportunities for Generic Drug Development},
  author={Robert A. Lionberger},
  journal={The AAPS Journal},
FDA’s critical path initiative documents have focused on the challenges involved in the development of new drugs. Some of the focus areas identified apply equally to the production of generic drugs. However, there are scientific challenges unique to the development of generic drugs as well. In May 2007, FDA released a document “Critical Path Opportunities for Generic Drugs” that identified some of the specific challenges in the development of generic drugs. The key steps in generic product… CONTINUE READING


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