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

Jack Sorokin, Deputy General Counsel (Retired), Beckman Coulter, Inc

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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USA Compliance Pharmaceutical February 2014 Vol. 7, No. 26, Winter 2014

Jack Sorokin

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. His practice covered the range of regulatory issues including medical device, environmental, occupational safety and health, hazardous materials, controlled substance and transportation. His practice also included corporate law and governance, SEC compliance, finance, risk management, supply chain, manufacturing, real estate, procurement and import/export law. He is currently teaching, writing and working as contract Counsel. He may be contacted by email at jesorokin@gmail.com.

Beckman Coulter, Inc

USA Compliance Pharmaceutical February 2014 Vol. 7, No. 26, Winter 2014