Articles

Lee Rosebush Authors Article on Compliance for Outsourcing Facilities Engaged in Clinical Investigation

Articles / February 23, 2016

BakerHostetler Partner Lee Rosebush, along with Francis B. Palumbo and Lowell M. Zeta, authored the article, “Navigating Through a Complex and Inconsistent Regulatory Framework: Section 503B of the Federal Food Drug and Cosmetic Act Outsourcing Facilities Engaged in Clinical Investigation,” published in the December 31, 2015, issue of Therapeutic Innovation & Regulatory Science.

The article points out that the U.S. pharmaceutical industry has invested $500 billion in research and development since 2002 and advises pharmacy compounders and other stakeholders to be acutely aware of the consequences of noncompliance. The article discusses inconsistencies in federal and state drug labeling regulations and explains that the regulatory landscape is governed by U.S. federal and state authorities competing for oversight and enforcement authority. Accordingly, the article advises researchers to be keenly aware of the implications of federal and state laws, including any inconsistencies, prior to engaging in clinical investigation.

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