federal_register: 2022-24432

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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
2022-24432 Sameness Evaluations in an Abbreviated New Drug Application-Active Ingredients; Draft Guidance for Industry; Availability Notice The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Sameness Evaluations in an ANDA--Active Ingredients." This guidance is intended to assist applicants preparing an abbreviated new drug application (ANDA) by providing recommendations on demonstrating sameness between the active ingredient in a proposed generic drug product and its reference listed drug (RLD). 2022-11-09 2022 11 https://www.federalregister.gov/documents/2022/11/09/2022-24432/sameness-evaluations-in-an-abbreviated-new-drug-application-active-ingredients-draft-guidance-for https://www.govinfo.gov/content/pkg/FR-2022-11-09/pdf/2022-24432.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and Drug Administration 221,199 The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Sameness Evaluations in an ANDA--Active Ingredients." This guidance is intended to assist applicants preparing an abbreviated new...  

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