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) - Softcover

The Law Library

Softcover

ISBN 10: 1727299531 ISBN 13: 9781727299533

Publisher: CreateSpace Independent Publishing Platform, 2018

Synopsis

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) 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 book 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 table of contents with the page number of each section

Edition details

• Publisher: CreateSpace Independent Publishing Platform
• Publication date: 2018
• Language: English
• ISBN 10: 1727299531
• ISBN 13: 9781727299533
• Binding: Paperback
• Number of pages: 32