federal_register: 2015-24621

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2015-24621 Controlled Correspondence Related to Generic Drug Development; Guidance for Industry; Availability Notice The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled "Controlled Correspondence Related to Generic Drug Development". The guidance document provides information regarding the process by which human generic drug manufacturers and related industry can submit correspondence to FDA requesting information on generic drug development. This guidance also describes FDA's process for providing communications related to such correspondence. 2015-09-29 2015 9 https://www.federalregister.gov/documents/2015/09/29/2015-24621/controlled-correspondence-related-to-generic-drug-development-guidance-for-industry-availability https://www.govinfo.gov/content/pkg/FR-2015-09-29/pdf/2015-24621.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled "Controlled Correspondence Related to Generic Drug Development". The guidance document provides information regarding the process by...

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