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YOUR GO-TO SOURCE FOR ANALYSIS OF ISSUES AFFECTING THE PHARMA & BIOTECH SECTORS
Selected TopicREMS
Through FDA’s Policy for Certain REMS Requirements During COVID-19 Public Health Emergency, FDA provides temporary relief from laboratory testing and imaging requirements for certain drugs and biologics subject to REMS with those specific prerequisites.
US President Donald Trump signed a pair of appropriations bills into law on December 20, including bipartisan legislation intended to facilitate the development of generic and biosimilar products.
In an attempt to minimize perceived obstacles to generic drug market entry, the FDA issued two draft guidance documents on May 31, 2018, related to shared system risk evaluation and mitigation strategies (REMS), providing the industry with insight into a previously underdefined area of FDA regulation.