• Regulatory NewsRegulatory News

    Generic Drugs Should Look Similar to the Drugs They Reference, FDA Says

    The US Food and Drug Administration (FDA) is recommending drugs made by generic manufacturers closely mimic the physical attributes, including the size, shape and color, of the drugs they reference. Background When FDA approves an abbreviated new drug application (ANDA), it does so primarily on the basis of a drug's bioequivalence to the Reference Listed Drug (RLD), the drug to which the generic is compared. Data must show a drug contains the same active ingredient, in ...
  • Even Animals Want Tasty Drugs, Argues EMA

    Animal drug products may not be expected to meet the same standards for safety and efficacy as their human-intended counterparts, but that doesn't mean that their eventual recipients don't appreciate a product that's easy on both their taste buds and sense of smell. That's the finding of a new draft guideline out from the European Medicines Agency (EMA), On the Demonstration of Palatability of Veterinary Medicinal Products , which lays out the requirements for veter...