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Regulatory News | 22 February 2017 | By Zachary Brennan
The massive 21st Century Cures Act, rushed to passage in the waning days of President Barack Obama’s presidency, features a whole host of provisions that will take years for the US Food and Drug Administration (FDA) and National Institutes of Health (NIH) to digest and implement, but it also includes several provisions that must be addressed by 13 March.
Among those provisions of the law that must be acted upon within 90 days of the law’s enactment (or by 13 March) include:
Section 2054 of the Act requires NIH to consult with stakeholders, including FDA and the Office of the National Coordinator for Health Information Technology, as well as patients, researchers, physicians, industry representatives and developers of health information technology to receive recommendations to further enhance ClinicalTrials.gov.
On Tuesday, several groups of researchers from the Association of Clinical Research Organizations (ACRO), Association of Clinical Research Professionals, Society for Clinical Research Sites and Coalition for Clinical Trials Awareness wrote to NIH officials calling on them “to adhere to this timeline for the benefit of patients everywhere who are awaiting new treatments and cures.”
While recognizing all federal agencies are undergoing a period of transition with the onboarding of new administration officials, the groups also call on NIH and other federal agencies to continue “to improve the functionality, utility and usability of the ClinicalTrials.gov database for the benefit of patients, researchers and other interested parties.”
In another three months, or by 13 June, other Cures deadlines have to be met, according to the law’s text, including:
Tags: 21st Century Cures, Cures Act, NIH and Cures, clinicaltrials.gov, patient experience data and FDA