Proposed requirements dictate a substantial upgrade of the current regulatory standard of care.
On October 29, the U.S. Food and Drug Administration (FDA or the Agency) issued a proposed rule—Current Good Manufacturing...more
On January 4, 2013, the Food and Drug Administration (FDA) issued two long-awaited proposed rules implementing important aspects of the 2011 Food Safety Modernization Act (FSMA). These rules are intended to help prevent...more
On January 4, 2013, the Food and Drug Administration (“FDA”) issued the first two rules that will put into effect the Food Safety Modernization Act (“FSMA”), a law passed by Congress in 2011 that is designed to prevent...more