Guidance to Industry and CDRH for PMAs and PMA Supplements: Use of Published Literature, Use of Previously Submitted Materials, and Priority Review; Draft; Availability

Streszczenie

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Guidance to Industry and CDRH for PMAs and PMA Supplements: Use of Published Literature, Use of Previously Submitted Materials, and Priority Review'' (the CDRH draft guidance). The FDA Modernization Act of 1997 (FDAMA) requires the agency to issue final guidance to clarify circumstances in which published matter may be the basis for approval of a supplemental application, specify data requirements that will avoid duplication of previously submitted data by recognizing the availability of data previously submitted in support of an original application, and define supplemental applications that are eligible for priority review. This document is being issued as a draft guidance.