Zdrowie i gospodarka · 09/07/2001

FDA Releases Draft Guidance for Clinical Trials Data Bank Implementation Plan

The Food and Drug Administration (FDA) has made available a draft guidance document outlining procedures for submitting protocol information to the Clinical Trials Data Bank, a requirement established under the Food and Drug Administration Modernization Act, and a follow-up to an earlier guidance on the scope of the Data Bank, published in 2000.