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Analyzing the Laws, Regulations, and Policies Affecting FDA-Regulated Products

Date: 12/01/2009
Author: John B. Reiss, Co-author; et al.
Industries: Health Care | Life Sciences

Publication: Food and Drug Law Journal

Winter 2009

John B. Reiss, a partner in the Business and Finance Department and a member of the Health Law and Life Sciences Practice Groups, co-wrote this article that examines agency behavior, court decisions and legislative or other developments that affect manufacturers of pharmaceuticals, medical devices and biotechnology products.

This year, the authors have included information concerning the food industry. As far as continuing trends are concerned, given the enhancements to the False Claims Act, it is clear that management of effective compliance programs must continue. In addition, while this year is likely to bring major policy changes as a result of the potential health reform legislation, the article predicts that the trends in agency activities and court decisions are likely to be maintained.