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A Path Through the Forest - The Role of Agency Guidance in Developing Regulatory Compliance Programs

Abstract

Counsel involved in developing regulatory compliance programs know that merely looking at the statute and regulations is not enough. They need to look to multiple sources of information to determine how the agency interprets the laws and regulations, and to understand agency expectations. Agency guidance documents play an important role in obtaining this information. This paper identifies the types of materials available and how they can be used. It also touches on the problems with these materials, including their nonbinding nature, and the benefits of using them.

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Author

Portrait image of Jack Sorokin
Jack Sorokin
Adjunct Instructor, Fremont College, USA

Jack Sorokin has had extensive experience as regulatory affairs counsel, most recently as Deputy General Counsel for Beckman Coulter, Inc., a leading international manufacturer and marketer of biomedical testing instrument systems, tests and supplies that simplify, automate and innovate complex laboratory processes. His practice has covered the range of regulatory issues, including medical device, environmental, occupational safety and health, hazardous materials, controlled substance, and transportation. His practice has also included corporate law and governance, SEC compliance, finance, risk management, supply chain, manufacturing, real estate, procurement, and import/export law. He retired from Beckman Coulter in June, 2012 and is currently an Instructor in the Fremont College Paralegal Studies Program.

Company

Fremont College

Beckman Coulter develops, manufactures and markets products that simplify, automate and innovate complex biomedical testing. The Company's diagnostic systems are found in hospitals and other critical care settings around the world and produce information used by physicians to diagnose disease, make treatment decisions and monitor patients. Scientists use Beckman Coulter's life science research instruments to study complex biological problems including causes of disease and potential new therapies or drugs. More than 275,000 Beckman Coulter systems operate in both diagnostics and life sciences laboratories on six continents

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