Hyman Phelps and McNamara
Firm Publications

Generic and Innovator Drugs: A Guide to FDA Approval Requirements, Eighth Edition
May 2013

The Eighth Edition of Generic and Innovator Drugs, coauthored by Kurt Karst, strives to continue the high level of discussion and analysis – specifically with regard to the Hatch-Waxman Amendments, and, more generally, with regard to the FDC Act – that readers have come to expect from the publication.

The Eighth Edition introduces several changes to the treatise, including an expanded text that accounts for significant changes to the law over the past five years, such as the Biologics Price Competition and Innovation Act and the FDA Safety and Innovation Act. The Eighth Edition also includes several new appendices

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If you have any questions regarding the above information, please contact:
Kurt R. Karst (202) 737-7544 kkarst@hpm.com