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eBook details

• Title: Current Good Manufacturing Practice and Investigational New Drugs Intended for Use in Clinical Trials - Final Rule (US Food and Drug Administration Regulation) (FDA) (2018 Edition)
• Author : The Law Library
• Release Date : January 06, 2018
• Genre: Law,Books,Professional & Technical,
• Pages : * pages
• Size : 147 KB

Description

The Law Library presents the complete text of the Current Good Manufacturing Practice and Investigational New Drugs Intended for Use in Clinical Trials - Final Rule (US Food and Drug Administration Regulation) (FDA) (2018 Edition).
Updated as of May 29, 2018

The Food and Drug Administration (FDA) is amending the current good manufacturing practice (CGMP) regulations for human drugs, including biological products, to exempt most phase 1 investigational drugs from complying with the regulatory CGMP requirements. FDA will continue to exercise oversight of the manufacture of these drugs under FDA's general statutory CGMP authority and through review of the investigational new drug applications (IND).

This ebook contains:
- The complete text of the Current Good Manufacturing Practice and Investigational New Drugs Intended for Use in Clinical Trials - Final Rule (US Food and Drug Administration Regulation) (FDA) (2018 Edition)
- A dynamic table of content linking to each section
- A table of contents in introduction presenting a general overview of the structure

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