federal_register: 2014-26306

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts regulation_id_numbers
2014-26306 Bioequivalence Recommendations for CONCERTA (Methylphenidate Hydrochloride) Extended-Release Tablets; Draft Guidance for Industry; Availability Notice The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Bioequivalence Recommendations for CONCERTA (methylphenidate hydrochloride) Extended- Release Tablets." The recommendations provide specific guidance on the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) that reference the listed drug CONCERTA (methylphenidate hydrochloride (HCl)) extended-release tablets (new drug application (NDA) 021121). The draft guidance is a revised version of a previously issued draft guidance on the same subject. 2014-11-06 2014 11 https://www.federalregister.gov/documents/2014/11/06/2014-26306/bioequivalence-recommendations-for-concerta-methylphenidate-hydrochloride-extended-release-tablets https://www.govinfo.gov/content/pkg/FR-2014-11-06/pdf/2014-26306.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Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Bioequivalence Recommendations for CONCERTA (methylphenidate hydrochloride) Extended- Release Tablets." The recommendations provide...  

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