The Learning Portal will be under maintenance Monday, 6 December between 6 AM and 5 PM EST. Portal functionality will be unavailable during this window.
We apologize for any inconvenience caused during this time.

  • Regulatory NewsRegulatory News

    French Regulator and Roche Trade Blows Over Off-Label Avastin Use

    On Monday, Swiss drugmaker Roche announced its opposition to the use of its cancer drug Avastin to treat wet age-related macular degeneration (AMD) in France. The move is aimed squarely at France's drug regulator, who temporarily recommended the drug for AMD as a cost saving maneuver in April 2015. Background Health authorities around the world have been eyeing Avastin (bevacizumab) as a cheaper alternative to Novartis' Lucentis (ranibizumab injection). After being app...
  • Regulatory NewsRegulatory News

    EU Regulators Concerned About Drug Data Fraud by Indian Company

    European regulatory officials have expressed concern that dozens of medicines may have been approved in the EU based on fraudulent data conducted by a contract testing facility in Hyderabad, India. Background In September 2014, French regulator ANSM raised concerns about GVK Biosciences, saying a good clinical practice (GCP) inspection had "raised serious concerns regarding the GCP compliance of the conduct of the clinical part of bioequivalence trials" at the company's...
  • French Regulators find Cardiology Manufacturer Non-Compliant with Regulations, Withdraw Devices

    • 15 May 2013
    French regulator ANSM has announced yet another problem-the second in as many weeks following a major scandal in 2012-this time with the Jarvik 2000 heart device due to violations of French laws and regulations by a manufacturer in the country. Background ANSM-Agence nationale de sécurité du médicament et des produits de santé, for those who prefer the full title-is a recent addition  to the world regulatory stage, having only been cr...
  • French Regulator Back in Spotlight as Another Device is Alleged to Have Evaded Controls

    • 03 May 2013
    French regulator ANSM is once again finding itself in position it is all too familiar with: The spotlight. After enduring several scandals over the last two years, most notably those related to pharmaceutical manufacturer Servier and implant manufacturer Poly Implant Prothese (PIP), the regulator is again facing uncomfortable questions after it was revealed that device manufacturer Ceraver had marketed hip implants that did not meet EU standards. Background ANSM-Agence ...
  • French Regulator Charged with Manslaughter for Role in Diabetes Drug Scandal

    • 22 March 2013
    French regulators have announced that judicial authorities have indicted the agency for its role in the regulation of the anti-diabetes drug Mediator, once manufactured by Servier and since blamed in the deaths of hundreds of French citizens. Background Mediator has been a drug plagued by scandal in recent years. A 2007  review  of the medication by the European Medicines Agency found that the use of the drug was dangerous in patients with high blood levels ...
  • CEO Charged with Manslaughter after Drug's Risks Brought to Light

    • 12 December 2012
    The eponymous head of the French pharmaceutical manufacturing group Servier, Jacques Servier, has been charged by a French court with manslaughter and causing injury in a case related to the company's now-discredited diabetes drug Mediator, reports The New York Times and Reuters . Servier, 90, was charged along with six of the Servier Group's companies over claims that the company knowingly and improperly marketed Mediator (benefluorex) without adequately disc...
  • France's ANSM Announces Launch of Nine Regulatory Pilot Projects

    • 29 October 2012
    French regulators have announced the results of an open call for regulatory projects aimed at improving the public health by improving how information is reported to patients and caregivers, how regulators investigate products with possible health risks to the public, and allowing patients to self-report adverse events to regulators. The projects are among the first for the recently-formed National Security Agency of Medicines and Health Products (ANSM), which was form...
  • French Regulators Launch New Prescription Drug Paradigm Aimed at Limiting Off-Label Use

    • 08 October 2012
    In the wake of a drug safety scandal that brought down an entire regulatory agency, France's new healthcare product regulatory body, ANSM, is moving to fundamentally change the way it regulates the use and surveillance of off-label prescription drug products, reports the New England Journal of Medicine (NEJM) . France's previous regulatory agency, AFSSAPS, was reconstituted in May 2012 as the National Agency for the Safety of Medicines and Health Products (ANSM) after...
  • France Issues New Advertising Guidelines

    • 04 June 2012
    France's recently-formed National Security Agency of Medicines and Health Products (ANSM) has announced the launch of new advertising guidelines, which it says will transition the agency from a passive verification system to a system in which advertising must be approved before publication. In its 31 May explanation of the "new methods of control" for advertising, ANSM notes requests for prior authorization must be sent to the agency per Article L.5122-9 of the Code of P...