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Postmarketing Safety Reporting for Combination Products (US Food and Drug Administration Regulation) (FDA) (2018 Edition) The Law Library

Postmarketing Safety Reporting for Combination Products (US Food and Drug Administration Regulation) (FDA) (2018 Edition) The Law Library presents the complete text of the Postmarketing Safety Reporting 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 regulations to set forth postmarketing safety reporting requirements for combination products. Specifically, this final rule describes the postmarketing safety reporting requirements that apply when two or more different types of regulated medical products (drugs, devices, and/or biological products, which are referred to as "constituent parts" of a combination product) comprise a combination product and the combination product or its constituent parts have received FDA marketing authorization. The rule is intended to promote and protect the public health by setting forth the requirements for postmarketing safety reporting for these combination products, and is part of FDA's ongoing effort to ensure the consistency and appropriateness of the regulatory requirements for combination products. This book contains: - The complete text of the Postmarketing Safety Reporting for Combination Products (US Food and Drug Administration Regulation) (FDA) (2018 Edition) - A table of contents with the page number of each section