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  • Regulatory NewsRegulatory News

    Trying to Treat or Cure a Rare Animal Disease? FDA Says it Wants to Help

    Have an idea for a new animal drug intended to help treat a rare disease in animals or an unusual creature? The US Food and Drug Administration (FDA) says it may have some funding for you. Background The money relates to a little-known regulatory designation established under the Minor Use and Minor Species Animal Health Act (MUMS Act) of 2004. Under the law, animal conditions are effectively treated as rare if they meet either of two conditions: If the condition a...
  • Regulatory NewsRegulatory News

    EMA Touts Big Year for Veterinary Products

    The European Medicines Agency (EMA) recommended 20 new veterinary medicines for approval in 2014, the highest number in the past five years, according to data provided by the regulator. The agency also boasts that it received 29 requests for classification of medicines intended for rare diseases or species with a small population, the most the agency has seen in a single year. Addressing Rare Diseases in Animals In 2009, EMA’s Committee for Medicinal Products for Vete...
  • Regulatory NewsRegulatory News

    What's a Rare Disease for Dogs? FDA Proposes Maintaining Current Levels for Major Species

    Drug regulation is in many ways as much about incentives as it is about requirements. Especially for drugs intended for smaller populations, an incentive—a free review voucher or a speedy review time, for example—may be the difference between a drug existing as a concept or as one available to consumers. Background In the US, patients have long benefited from the Orphan Drug Act , which defines a rare disease as one affecting fewer than 200,000 patients in a given year...