• Regulatory NewsRegulatory News

    Senators Grill CMS on Incorporating UDIs Into Insurance Claims Forms

    Senators Elizabeth Warren (D-MA) and Charles Grassley (R-IA) questioned the Centers for Medicare and Medicaid Services' (CMS) opposition to incorporating the unique device identifier (UDI) for medical devices into insurance claims forms. By not adding UDIs to insurance claims forms, Warren and Grassley warn that Medicare is making it more difficult to monitor device safety, which has resulted in millions of claims that could have been avoided with better monitoring. In ...
  • Feature ArticlesFeature Articles

    Answering the Call for Excellence in Regulatory Education

    The regulatory landscape has evolved dramatically in the last few decades. Today’s regulatory professionals perform key functions in their organizations, including ensuring compliance with regulations and facilitating the development and commercialization of new products. These professionals must be equipped to address the increased complexity of the modern regulatory landscape. One important way to prepare is through graduate studies. Graduate education in regulatory pla...
  • EMA Releases Updated Final Guideline on Active Substance Master Files

    A new final guideline published on 13 July 2012 by the European medicines Agency (EMA) updated the Active Substance Master File (ASMF) Procedure -its first upgrade since its formation in 2006. The ASMF procedure, formerly known as the European Drug Master File (EDMF) procedure, is used to protect confidential intellectual property information while allowing regulatory agencies to access a more complete picture regarding how an active substance is manufactured. Both EMA a...
  • Massachusetts Loosens Ban on Industry Gifts

    • 10 July 2012
    The state of Massachusetts is loosening its controversial policy banning the pharmaceutical and medical device industries from giving physicians gifts, including compensated meals during continuing medical education. The measure has come under increasing fire in recent years as the economy has come to dominate matters of political discussion. Massachusetts' restaurant industry claimed the measure was hurting business as pharmaceutical companies no longer wined-and-dine...
  • Massachusetts Moves to Implement Quality System

    Massachusetts is working to implement a system that would change how the state reimburses hospitals and doctors, according to a report in The Boston Globe . The new system would reward providers that are able to lower their treatment costs while improving the quality of care provided to patients. "By examining the standards by which health care quality will be uniformly measured, we can do a much better job of understanding the value of care we are purchasing," wrote...