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federal_register: 06-4091

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
06-4091 Current Good Manufacturing Practice Regulation and Investigational New Drugs; Withdrawal Rule The Food and Drug Administration (FDA) is withdrawing the direct final rule that published in the Federal Register of January 17, 2006, to amend its current good manufacturing practice (CGMP) regulations for human drugs, including biological products, to exempt most investigational "Phase 1" drugs from complying with the requirements in FDA's regulations. FDA is withdrawing the rule because significant adverse comments were received. 2006-05-02 2006 5 https://www.federalregister.gov/documents/2006/05/02/06-4091/current-good-manufacturing-practice-regulation-and-investigational-new-drugs-withdrawal https://www.govinfo.gov/content/pkg/FR-2006-05-02/pdf/06-4091.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is withdrawing the direct final rule that published in the Federal Register of January 17, 2006, to amend its current good manufacturing practice (CGMP) regulations for human drugs, including biological products,...

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