federal_register: 2018-06253

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
2018-06253 Product-Specific Guidance for Doxycycline Hyclate; Revised Draft Guidance for Industry; Availability Notice The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised draft guidance for industry on generic doxycycline hyclate oral delayed-release tablets, entitled "Product- Specific Guidance for Doxycycline Hyclate." The revised draft guidance, when finalized, will provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for doxycycline hyclate oral delayed-release tablets. 2018-03-29 2018 3 https://www.federalregister.gov/documents/2018/03/29/2018-06253/product-specific-guidance-for-doxycycline-hyclate-revised-draft-guidance-for-industry-availability https://www.govinfo.gov/content/pkg/FR-2018-03-29/pdf/2018-06253.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Administration 221,199 The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised draft guidance for industry on generic doxycycline hyclate oral delayed-release tablets, entitled "Product- Specific Guidance for Doxycycline Hyclate." The...

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