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Current Good Manufacturing Practice Requirements for Combination Products (Us Food and Drug Administration Regulation) (Fda) (2018 Edition) The Law Library

Current Good Manufacturing Practice Requirements for Combination Products (US Food and Drug Administration Regulation) (FDA) (2018 Edition) The Law Library presents the complete text of the Current Good Manufacturing Practice Requirements for Combination Products (US Food and Drug Administration Regulation) (FDA) (2018 Edition). Updated as of May 29, 2018 The Food and Drug Administration (FDA or Agency) is issuing this regulation on the current good manufacturing practice (CGMP) requirements applicable to combination products. This rule is intended to promote the public health by clarifying which CGMP requirements apply when drugs, devices, and biological products are combined to create combination products. In addition, the 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. This book contains: - The complete text of the Current Good Manufacturing Practice Requirements for Combination Products (US Food and Drug Administration Regulation) (FDA) (2018 Edition) - A table of contents with the page number of each section