federal_register: 2017-22891

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
2017-22891 Product-Specific Guidance for Methylphenidate Hydrochloride; New Draft Guidance for Industry; Availability Notice The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a new draft guidance for industry on generic methylphenidate hydrochloride oral extended-release tablets entitled "Draft Guidance on Methylphenidate Hydrochloride." The new draft guidance, when finalized, will provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new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 methylphenidate hydrochloride oral extended-release tablets. 2017-10-23 2017 10 https://www.federalregister.gov/documents/2017/10/23/2017-22891/product-specific-guidance-for-methylphenidate-hydrochloride-new-draft-guidance-for-industry https://www.govinfo.gov/content/pkg/FR-2017-10-23/pdf/2017-22891.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a new draft guidance for industry on generic methylphenidate hydrochloride oral extended-release tablets entitled "Draft Guidance on Methylphenidate...

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