Risk Evaluation and Mitigation Strategies for US Drug Development, Second Edition (e-book)
Table of Contents
Chapter 1: The Limits of Risk and the Concept of the REMS
Chapter 2: Pharmaceutical Risk Management Plans Before REMS
Chapter 3: When is a REMS needed?
Chapter 4: Medication Guides: Components of REMS from 2008–2011
Chapter 5: Components of a REMS: Communication Plans and Implementation Systems
Chapter 6: Components of a REMS: Elements to Assure Safe Use (ETASU)
Chapter 7: Components of a REMS: REMS Assessment
Chapter 8: Anticipating, Preparing and Filing a REMS
Chapter 9: Modifying a REMS; Being Released From a REMS
Chapter 10: REMS for Entire Drug Classes
Chapter 11: REMS and the Opioid Crisis
Chapter 12: REMS for Drugs for Use in Infants, Children and Adolescents
Chapter 13: Effect of a REMS on the Speed of Review and Approval of New Drugs
Chapter 14: The Impact of REMS on Generic Drug Approvals and Drug Competition
Chapter 15: Effects of the REMS Program on the Healthcare System and Pharmaceutical Competition
Chapter 16: The Evolving REMS Process
Chapter 17: Guidance Documents and Databases on REMS
Edward Tabor, MD
About the Book
Available formats: print and e-book
The second edition of this comprehensive analysis of the FDA REMS program has been extensively rewritten to include new aspects of REMS introduced by FDA since the original book was published in 2012. Numerous guidance documents and policy decisions have markedly changed the REMS development requirements, format and process. These new guidance documents and recent REMS approvals are discussed to provide insight into how FDA has dealt with REMS requirements in recent years.
REMS have had an impact on important medical issues. The way FDA has tried to prevent some manufacturers from using their REMS to discourage generic version of their products’ entry into the market is thoroughly analyzed. The book examines, in detail, FDA’s use of REMS growing effort to try to limit the overuse, misuse and abuse of prescription opioids.
Whether you’re in the midst of submitting a new drug to FDA or pursuing approval for a generic version of an innovator product that already has a REMS, this is an essential publication.
Who will benefit from this book?
Regulatory professionals working in the development of high-risk products that may require a REMS—including the development of generic versions of innovator products that have REMS—will find this resource invaluable as they seek FDA approval.
Purchasing Options
This book can be purchased in the following formats:
- Digital e-book. Single purchase; accessible online via RAPS Library online reader and downloadable.
- Printed book.
This book can also be purchased as part of the following bundles:
- All Access Library (12-month digital subscription)
Published by RAPS © 2018. Paperback. 157 pages. ISBN (print): 978-1-947493-23-0. ISBN (digital): 978-1-947493-24-7.
