federal_register: 2016-06886

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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
2016-06886 Investigational New Drug Applications for Biological Products; Bioequivalence Regulations; Technical Amendment Rule The Food and Drug Administration (FDA or Agency) is amending its regulations to update the address for applicants to submit investigational new drug applications (INDs) for biological products regulated by the Center for Drug Evaluation and Research (CDER). FDA is also amending its regulations on the criteria and evidence to assess actual and potential bioequivalence problems (bioequivalence regulations) to correct a typographical error. FDA is taking this action to ensure accuracy and clarity in the Agency's regulations. 2016-03-28 2016 3 https://www.federalregister.gov/documents/2016/03/28/2016-06886/investigational-new-drug-applications-for-biological-products-bioequivalence-regulations-technical https://www.govinfo.gov/content/pkg/FR-2016-03-28/pdf/2016-06886.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA or Agency) is amending its regulations to update the address for applicants to submit investigational new drug applications (INDs) for biological products regulated by the Center for Drug Evaluation and Research...  

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