federal_register: 2013-18236

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2013-18236 Guidance for Industry: Safety Labeling Changes-Implementation of Section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act; Availability Notice The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled "Safety Labeling Changes--Implementation of Section 505(o)(4) of the FD&C Act." The Food and Drug Administration Amendments Act of 2007 (FDAAA) added new provisions to the Federal Food, Drug, and Cosmetic Act (the FD&C Act) authorizing FDA to require certain drug and biological product application holders to make safety-related labeling changes based upon new safety information that becomes available after the drug or biological product is approved under the FD&C Act or the Public Health Service Act (the PHS Act). This final guidance provides information on the implementation of section 505(o)(4) of the FD&C Act, including a description of the types of safety labeling changes that ordinarily might be required under this section; how FDA plans to determine what constitutes new safety information; the procedures involved in requiring safety labeling changes; and enforcement of the requirements for safety labeling changes. 2013-07-30 2013 7 https://www.federalregister.gov/documents/2013/07/30/2013-18236/guidance-for-industry-safety-labeling-changes-implementation-of-section-505o4-of-the-federal-food https://www.govinfo.gov/content/pkg/FR-2013-07-30/pdf/2013-18236.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 "Safety Labeling Changes--Implementation of Section 505(o)(4) of the FD&C Act." The Food and Drug Administration Amendments Act of 2007 (FDAAA)...  

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