federal_register: 2014-30109

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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
2014-30109 Bioequivalence Recommendations for Methylphenidate Hydrochloride Extended-Release Oral Suspension; Draft Guidance for Industry; Availability Notice The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Bioequivalence Recommendations for Methylphenidate Hydrochloride Extended-Release Oral Suspension." The recommendations provide specific guidance on the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for methylphenidate hydrochloride (HCl) extended- release oral suspension. 2014-12-24 2014 12 https://www.federalregister.gov/documents/2014/12/24/2014-30109/bioequivalence-recommendations-for-methylphenidate-hydrochloride-extended-release-oral-suspension https://www.govinfo.gov/content/pkg/FR-2014-12-24/pdf/2014-30109.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Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Bioequivalence Recommendations for Methylphenidate Hydrochloride Extended-Release Oral Suspension." The recommendations provide specific...  

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