federal_register: 2015-15076

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2015-15076 Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules; Guidance for Industry; Availability Notice 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. 2015-06-19 2015 6 https://www.federalregister.gov/documents/2015/06/19/2015-15076/size-shape-and-other-physical-attributes-of-generic-tablets-and-capsules-guidance-for-industry https://www.govinfo.gov/content/pkg/FR-2015-06-19/pdf/2015-15076.pdf Health and Human Services Department; Food and Drug Administration 221,199 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...  

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