Are You Ready for FDA Inspection of Your Disclosure Practices?

In 2007, the Food and Drug Administration Amendments Act (FDAAA) was passed. Title VIII of this act requires sponsors to register and provide results for Applicable Clinical Trials (ACTs) on a public database.

Responsibility for implementation was given to the National Library of Medicines (NLM), which used the existing ClinicalTrials.gov database and website to fulfill their obligation. In September of 2012 the Food and Drug Administration (FDA) was given the authority to enforce compliance with FDAAA.

In September 2016, two disclosure-related items made the news in the U.S. The first was the issuance of “42 CFR Part 11, Clinical Trials Registration and Results Information Submission,” commonly referred to as the “Final Rule.” Anticipated since 2009, the Final Rule clarifies and enhances requirements for registering clinical trials and disclosing results.

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