FDA's Focus On Drug Appearance May Cause Ugly Problems

Law360, New York (August 25, 2015, 10:39 AM EDT) -- Jeffrey A. Wolfson

Evert Tu The U.S. Food and Drug Administration recently issued final guidance regarding the size, shape and other physical characteristics of generic-manufactured tablet and capsule dosage forms. The guidance noted that differences in physical characteristics of a dosage form could affect patient compliance and acceptability of medication regimens or could lead to medication errors. The main reason for the FDA’s guidance appears to be that many patients can experience difficulty swallowing tablets and capsules. But these issues can create impacts on the cost and availability of generic drugs and may require an additional class of patents to be...

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