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federal_register: E8-7107

All Federal Register documents (rules, proposed rules, notices, presidential documents) from 1994 to present. Nearly 1M documents with full-text search.

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
E8-7107 Amendment to the Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals; Withdrawal Rule The Food and Drug Administration (FDA) is withdrawing a direct final rule that published in the Federal Register of December 4, 2007 (72 FR 68064), to amend certain regulations as the first phase of an incremental approach to modernize or clarify some of the current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, as well as harmonize some of the CGMP requirements with those of other foreign regulators and other FDA regulations. The comment period closed February 19, 2008. FDA is withdrawing the direct final rule because the agency received significant adverse comments. FDA will consider the comments received under our usual procedures for notice and comment in connection with the notice of proposed rulemaking that was published in the Federal Register of December 4, 2007, as a companion to the direct final rule (72 FR 68113). 2008-04-04 2008 4 https://www.federalregister.gov/documents/2008/04/04/E8-7107/amendment-to-the-current-good-manufacturing-practice-regulations-for-finished-pharmaceuticals https://www.govinfo.gov/content/pkg/FR-2008-04-04/pdf/E8-7107.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is withdrawing a direct final rule that published in the Federal Register of December 4, 2007 (72 FR 68064), to amend certain regulations as the first phase of an incremental approach to modernize or clarify some...

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