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  • Regulatory NewsRegulatory News

    Brazil's Anvisa Pushes Expedited Approvals for Generics, Biologics

    Brazilian regulator Anvisa has launched a simplified procedure (RDC No. 31) for the registration, post-registration and renewal of registration of generic, similar, herbal, biologic, “dynamized” and “specific” drugs.  So-called "dynamized" drugs in Brazil are preparations from substances that are subjected to successive dilutions, that are administered as homeopathic, anthroposophic or homotoxicological therapy.  Specific drugs are products that do not fit int...
  • FDA Launches Renewal Process for Animal Drug User Fees With New Proposals

    • 04 December 2012
    The US Food and Drug Administration (FDA) is preparing for two meetings on both branded and generic veterinary pharmaceutical products, part of the impending renewal of two user fee acts meant to fund the agency's reviews and other regulatory activities in return for more accountability. The two user fee bills-the Animal Drug User Fee Act (ADUFA) and Animal Generic Drug User Fee Act (AGDUFA) -act in much the same way as those for human prescription drug products, med...