Inspections are anticipated to begin in the near future and the risk of non-compliance will have a financial impact. 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…
Storm Warning: The Trial Disclosure Forecast for 2017
2017 will be a challenging year marked by public scrutiny of disclosure practices by regulators, stakeholders, and watchdog organizations. Expanded regulations require a significantly broader range of data to be disclosed within ever tighter timelines. 2016 saw renewed scrutiny of the transparency practices of industry and academic sponsors and the implementation of expanded disclosure regulations.…