• RAPS' LatestRAPS' Latest

    Outstanding Contributions Deserve Outstanding Recognition

    Nominations are now open for RAPS awards, which go to regulatory professionals with diverse, global backgrounds. The RAPS Awards Committee is currently seeking nominations for RAPS' annual awards honoring outstanding regulatory professionals in the healthcare products sector. RAPS' awards programs provide an important opportunity to acknowledge outstanding individual contributors to the regulatory field. This year, the committee has made significant improvements to the...
  • FDA Sends Warning Letter For Lack of Quality Agreement

    • 23 February 2012
    The US Food and Drug Administration (FDA) sent a warning letter to FSC Laboratories for failure to establish a quality agreement with the manufacturer of its drug delivery device, according to a report by Outsourcing Pharma . The letter, written in June, but published this week, found FSC's overall quality plan "adequate," but FDA raised several points for the company to examine. Outsourcing Pharma reported quality agreements are important to FDA. Acting associa...