cGMPs

FDA Updates Regulatory Agenda

Source: PharmaManufacturing.com

Jul 15, 2013

RAPS.org

Recently the U.S. Department of Health and Human Services released its updated Unified Agenda for the rest of 2013, including dozens of final and proposed regulations set to be released by the U.S. Food and Drug Administration (FDA), including a proposed rule on ANDA and 505 (b) (2) applications relating to patent certifications, and a proposed revision to current GMP regulations for finished pharmaceuticals. See full story here.