On
The study in question involved a Phase 2 randomized, double-blind clinical trial comparing the combination of dalantercept and axitinib to placebo plus Axitinib in patients with advanced renal cell carcinoma. After the trial failed to reach its primary endpoint, Acceleron discontinued the development of dalantercept in 2017.
A responsible party, typically a clinical trial sponsor or sponsor investigator, of an applicable clinical trial (any clinical trial (other than a device feasibility trial or a phase I drug trial) to collect data to support an FDA premarket submission) is required to submit to ClinicalTrials.gov certain information about the results of such a clinical trial; this information generally must be submitted no later than one year after the primary completion date of the applicable clinical trial unless an exception applies. See section 402(j)(3)(E) of the Public Health Service Act (PHS Act) (42 U.S.C. § 282(j)(3)(E)). The responsible party can submit a certification of delay, a request for an extension of good cause, or a request for a waiver of the requirements for submission of results information. See 42 C.F.R. § 11.44, and section 402(j)(3)(H) of the PHS Act (42 U.S.C. § 282(j)(3)(H)). The responsible party is also required to register applicable clinical trials on ClinicalTrials.gov within 21 days after the first human subject is enrolled in the applicable clinical trial.
In the letter sent in April, FDA stated it acted after warning Acceleron in
According to a recent statement by FDA, the legal requirements applicable to Clinicaltrials.gov reporting are intended to provide greater transparency about the results of completed clinical trials to allow for the scientific community to build on submitted information. FDA stated that it "takes its role in enforcing the ClinicalTrials.gov registration and results information submission requirements extremely seriously and we will continue to encourage voluntary compliance with these requirements." The Agency further stated it will take appropriate actions when necessary to ensure that required information is available on ClinicalTrials.gov as required by the law. This recent turn of events may signal a new wave of enforcement actions against companies who fail to comply with these statutory and regulatory requirements related to ClinicalTrials.gov.
Foley is here to help you address the short- and long-term impacts in the wake of regulatory changes. We have the resources to help you navigate these and other important legal considerations related to business operations and industry-specific issues. Please reach out to the authors, your Foley relationship partner, or to our
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