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Final Rule Re Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products - Safety Reporting Requirements (Us Food and Drug Administration Regulation) (Fda) (2018 Edition) The Law Library

Final Rule re Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products - Safety Reporting Requirements (US Food and Drug Administration Regulation) (FDA) (2018 Edition) The Law Library presents the complete text of the Final Rule re Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products - Safety Reporting Requirements (US Food and Drug Administration Regulation) (FDA) (2018 Edition). Updated as of May 29, 2018 The Food and Drug Administration (FDA) is amending its regulations governing safety reporting requirements for human drug and biological products subject to an investigational new drug application (IND). The final rule codifies the agency's expectations for timely review, evaluation, and submission of relevant and useful safety information and implements internationally harmonized definitions and reporting standards. The revisions will improve the utility of IND safety reports, reduce the number of reports that do not contribute in a meaningful way to the developing safety profile of the drug, expedite FDA's review of critical safety information, better protect human subjects enrolled in clinical trials, subject bioavailability and bioequivalence studies to safety reporting requirements, promote a consistent approach to safety reporting internationally, and enable the agency to better protect and promote public health. This book contains: - The complete text of the Final Rule re Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products - Safety Reporting Requirements (US Food and Drug Administration Regulation) (FDA) (2018 Edition) - A table of contents with the page number of each section