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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 should use this publication?

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.

Published by RAPS © 2018. Paperback. 157 pages.