federal_register: 2013-29395

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2013-29395 Draft Guidance for Industry on Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules; Availability Notice The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules."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. 2013-12-10 2013 12 https://www.federalregister.gov/documents/2013/12/10/2013-29395/draft-guidance-for-industry-on-size-shape-and-other-physical-attributes-of-generic-tablets-and https://www.govinfo.gov/content/pkg/FR-2013-12-10/pdf/2013-29395.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules."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,...

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