RAPS: 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. 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 that companies will need to ensure the physical differences between a generic drug and the drug it references aren\'t clinically meaningful.