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Clinical Data Disclosure Newsletter

February 1, 2010

Early on in the clinical trial disclosure initiative, many in the pharmaceutical/biotech/medical device industry naively believed that when a legislative bill was signed into law, we could confidently put internal compliance procedures in place without worry that the law would change in the near future. Unfortunately, our innocent views of legislative processes were soon altered when Maine changed its initial clinical trial disclosure requirements.

Now, clinical trial disclosure laws and regulations (local, regional, and global) seem to evolve on an almost-daily basis. Even since the passage of the extensive requirements of the Food and Drug Administration Amendments Act of 2007, Maine continues to amend its rules and regulations on clinical trial disclosure.

Here, we summarize the major changes to the Maine regulations, which were instituted in November of 2009 and became effective January 1, 2010.