federal_register: E9-22850

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
E9-22850 Current Good Manufacturing Practice Requirements for Combination Products Proposed Rule The Food and Drug Administration (FDA or agency) proposes to codify the current good manufacturing practice (cGMP) requirements applicable to combination products. This proposed rule is intended to promote the public health by clarifying which cGMP requirements apply when drugs, devices, and biological products are combined to create a combination product. In addition, the proposed rule sets forth a transparent and streamlined regulatory framework for firms to use when demonstrating compliance with cGMP requirements for "single-entity" and "co-packaged" combination products. 2009-09-23 2009 9 https://www.federalregister.gov/documents/2009/09/23/E9-22850/current-good-manufacturing-practice-requirements-for-combination-products https://www.govinfo.gov/content/pkg/FR-2009-09-23/pdf/E9-22850.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA or agency) proposes to codify the current good manufacturing practice (cGMP) requirements applicable to combination products. This proposed rule is intended to promote the public health by clarifying which cGMP...

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