Zdrowie i gospodarka · 10/12/2013

Draft Guidance for Industry on Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules; Availability

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules." This guidance discusses FDA recommendations for the size, shape, and other physical attributes of generic tablets intended to be swallowed intact. FDA is concerned that these characteristics of generic drugs are too varied compared to the originator drug and could affect patient outcomes.