• 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 ...
  • Regulatory NewsRegulatory News

    FDA to Study Effect of Generic Drug Appearance on Patient Adherence

    Does the color, shape or size of a generic drug affect how willing patients are to adhere to existing treatment regimens? The US Food and Drug Administration (FDA) wants to know. Background FDA has long been interested in the physical attributes of drugs, and in particular generic drug products. In December 2013, for example, it released a new guidance document, Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules . In it, FDA explained tha...