• New Rules to Voluntarily Restrict Prescription Drug and Device Marketing in Ireland

    Pharmaceutical and medical devices industries doing business in Ireland may soon find it more difficult to market their products under new guidance developed by the Irish Medical Council aimed at redefining the terms of acceptable conduct between doctors and members of industry. The guidance, a supplement to earlier guidance on the same topic, is specifically aimed at reducing real or perceived conflicts of interest, the majority of which are caused by gifts and othe...
  • Department of Justice Seeks Dismissal of Whistleblowers' Case Against FDA

    The Department of Justice (DOJ) has filed a motion to dismiss a lawsuit brought against the US Food and Drug Administration (FDA) by several current and former agency employees after FDA allegedly spied on their whistleblowing activities to members of Congress and other oversight agencies. DOJ's motion, filed on 1 October-almost exactly a year after the case was first filed-seeks dismissal based on a "lack of jurisdiction." Bloomberg explains DOJ argues that an...
  • Investigation into FDA Reveals 'Enemies List,' Extensive Monitoring Practices

    An investigation into the US Food and Drug Administration (FDA) by The New York Times has revealed the agency established an extensive monitoring program aimed at both restricting leaks of confidential information and establishing what The Times refers to as "an enemies list of sorts." The agency is currently under investigation--and is being sued by--various groups who allege the agency spied on its own employees, violating both whistleblower protection laws and v...
  • US Regulators Approve First Over-the-counter HIV Test Kit

    Regulators at the US Food and Drug Administration (FDA) announced Tuesday, 3 July the approval of an over-the-counter (OTC) home testing kit for the detection of the Human Immunodeficiency Virus (HIV)-the first of its kind to be approved. The test, called the OraQuick In-Home HIV Test, is manufactured by Pennsylvania-based OraSure Technologies, Inc. OraQuick received overwhelming approval from FDA's Blood product Advisory Committee in May 2012, voting 17-0 to recomme...
  • OTC Test for HIV Approved by FDA Advisory Panel

    The US Food and Drug Administration's (FDA) Blood Products Advisory Committee voted 17-0 on 15 May to recommend OraSure's In-Home OraQuick HIV Test, the first such product to be approved for over-the-counter (OTC) testing for the Human Immunodeficiency Virus (HIV). According to clinical studies, the device is 99.98% effective at determining whether or not a person is infected with the HIV virus. The product had been faced with some early concerns about the accuracy of t...
  • Brazil: Advisory Council Discusses New ANVISA

    ANVISA's Advisory Council -a group including representatives of the National Confederations of Industry (CNI), Commerce (CNC) and Health (CNS) and councils that represent the health secretaries of Brazilian states and municipalities-came together to discuss the new structure of the Brazilian regulatory agency at its 38 th meeting on 18 April 2012. The restructuring also resulted in the development of a Strategic Plan for the agency for the coming years, which the Counc...