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  • EMA Invites Comments on ICH Risk-Benefit Guidance

    The European Medicines Agency (EMA) is inviting comments on newly-released guidance by the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) that seeks to harmonize standards between the US, EU and other countries. ICH's standard, E2C(R2): Periodic Benefit-Risk Evaluation Report , was released by the organization 2 March 2012. The US Food and Drug Administration quickly followed suit, rele...
  • Consumers Union Gears Up To Go After 510(k) Program, Urges MDUFA Markup

    Consumers Union, best known for their Consumer Reports publication, is launching a campaign to persuade Congress to force manufacturers using the 510(k) medical device regulation pathway to subject their products to the same premarket safety and efficacy tests that are required of pharmaceutical products. The 510(k) pathway is used by medical device manufacturers, and requires that manufacturers notify the US Food and Drug Administration (FDA) that they plan to market ...