Monthly Archives:
July 2015

FDA Finalizes Six-Month Drug Shortage Notice Regulation

From the Regulatory Affairs Professionals Society (RAPS) June 8, 2015 By Michael Mezher A regulation proposed by the US Food and Drug Administration (FDA) in 2013 will take effect on 8 September, requiring drug and biologics manufacturers to notify the agency in advance of impending drug shortages. Background In 2011, after several years of worsening […]