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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