The Food and Drug Administration (FDA) is announcing the availability of a 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 and capsules intended to be swallowed intact. FDA is concerned that differences in these physical characteristics between generic drugs and the originator drug could affect patient outcomes.
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Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules; Guidance for Industry; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Size, Shape, and Other Physical Attributes of Generic Tablets and Cap...
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80 FR 35366
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“Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules; Guidance for Industry; Availability,” thefederalregister.org (June 19, 2015), https://thefederalregister.org/documents/2015-15076/size-shape-and-other-physical-attributes-of-generic-tablets-and-capsules-guidance-for-industry-availability.