FDAMA PMA supplement guidance
This article was originally published in The Gray Sheet
Executive Summary
FDA releases a draft guidance March 26 implementing Sec. 403(b) of the FDA Modernization Act, which calls for the agency to describe: when published matter may be the basis of a supplemental application; data requirements that avoid duplication of previously submitted material; and which supplements are eligible for priority review. The document, available at www.fda.gov/cdrh/modact/modguid.html, is being issued for comment in advance of the FDAMA-mandated May 20 publication date for the final version