Department of Health and Human Services September 14, 2007 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions.'' FDA is issuing this guidance to clarify the regulations regarding commercially distributed ASRs and the role and responsibilities of ASR manufacturers. The draft of this guidance was issued September 7, 2006.