Guidance for Industry on FDA Approval of New Cancer Treatment Uses for Marketed Drug and Biological Products; Availability

Streszczenie

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``FDA Approval of New Cancer Treatment Uses for Marketed Drug and Biological Products.'' The guidance considers the quality and quantity of data that may be adequate to add a new use to the prescribing information for a product used in the treatment of cancer. The guidance is part of an agency effort to encourage the submission of supplemental applications for new uses for approved drug and biological products. This guidance is consistent with the Food and Drug Administration Modernization Act of 1997 (the Modernization Act), which specifies that the agency will continue its efforts to encourage sponsors to submit supplemental applications for new uses for their products.