FDA's Focus On Drug Appearance May Cause Ugly Problems


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 evaluated in clearing third-party patent rights when filing an ANDA and certain 505(b)(2) applications.

As appeared in Law360 on August 25, 2015. To read the full article, click here (subscription required).

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