• Regulatory NewsRegulatory News

    EU Notified Bodies Update Code of Conduct

    Content provided by Emergo Group , a medical device regulatory affairs and quality assurance consulting firm with offices worldwide. The European Association for Medical Devices of Notified Bodies (Team-NB) has published an updated Code of Conduct targeting more consistent and transparent CE Mark certifications from member firms. First implemented by Team-NB in early 2013, the Code of Conduct’s version 3.2 makes more explicit processes and procedures Notified B...
  • Regulatory NewsRegulatory News

    Perspectives on the FDASIA Health IT Report and Public Workshop

    On 7 April 2014, a Food and Drug Administration Safety and Innovation Act ( FDASIA )-mandated workgroup issued its strategy and regulatory framework document on health IT to Congress. 1 The workgroup is comprised of representatives from the US Food and Drug Administration (FDA), the Federal Communications Commission (FCC) and the Office of the National Coordinator for Health Information Technology (ONC). A public workshop was held 13–15 May 2014 to discuss the pr...
  • Fund to Provide for England's Thalidomide Victims

    • 21 December 2012
    This year marked two important anniversaries in the regulatory community. In the US, regulators noted the 50 th anniversary of the passage of the Kefauver-Harris Amendments to the Federal Food, Drug and Cosmetic Act (FD&C Act), a piece of legislation aimed at improving regulatory oversight over healthcare products. Worldwide, regulators marked a more ominous anniversary: 50 years since the drug Thalidomide was introduced to the world . The introduction of t...
  • Trade Group Calls for Mutual Inspection Regime to Safeguard API Supply Chain

    • 13 November 2012
    The European Fine Chemical Group (EFCG) , an industry association of chemical manufacturers-including more than 150 devoted to pharmaceutical manufacturing-is calling for mandatory inspections of all global active pharmaceutical ingredient (API) manufacturing sites through the use of mutual recognition agreements. In a 12 November statement, EFCG said it was, "Proposing a global harmonization of the rules and regulations governing the manufacture of APIs to level the wo...
  • After 50 Years, Victims Finally Receive Apology from Thalidomide Manufacturer

    • 04 September 2012
    More than half a century after German drug manufacturer Grünenthal Group set into motion a new era of global drug regulation after its morning sickness drug Thalidomide was linked to deaths and serious birth defects, the company has offered something long sought by activists: an apology. Speaking at an unveiling of a Thalidomide Memorial in Rhineland, Germany, Grünenthal CEO Harald Stock offered his "sincere regrets" and "deep sympathy for all those affec...
  • ICH Looking to Establish New Harmonized Guideline on Carcinogenicity Testing

    The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) announced 14 May it has established a concept paper and business paper for a new expert working group (EWG) aiming to develop guidance on rodent carcinogenicity testing. "The aim of this new topic is to introduce a more comprehensive and integrated approach to addressing the risk of human carcinogenicity of pharmaceuticals, and also to clar...
  • Patient Group Collaborations Continue as Sanofi, Michael J Fox. Foundation Team Up

    • 20 April 2012
    Following in the footsteps of other successful partnerships between pharmaceutical manufacturers and patient groups, French life sciences company Sanofi is teaming up with the Michael J. Fox Foundation (MJFF) to collaborate on testing a new treatment for Parkinson's disease. The partnership will test a compound known as AVE 8112, a phosphodiesterase type 4 inhibitor, in a phase 1 b clinical trial to assess the drug's safety and tolerability, Sanofi said in a statement. ...