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Form 1572 Update May 21, 2021

Posted by Michael Hamrell in Uncategorized.
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On May 20, 2021 the FDA released a Draft Guidance on updates to the previous guidance on the use of the Form 1572, Statement of Investigator. In particular, the draft addresses issues around the use of the form for Investigators outside of the US and waivers to the need for ex-US Investigators to sign the form.

https://www.fda.gov/media/148810/download

Compliance with ClinicalTrials.gov May 14, 2021

Posted by Michael Hamrell in Current Thoughts.
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In April 2021 the FDA sent a Notice of Noncompliance to a firm for failing to comply with the requirements to submit clinical trial results information to the ClinicalTrials.gov data bank for one of their clinical trials. The regulation requires a firm to submit certain results information for the clinical trials no later than one year after completion date of the applicable clinical trials (42 CFR ยง11). The firm had previously been instructed by FDA in July 2020 to update their listing with the required results information. If this information is not submitted with 30 calendar days after the letter, the FDA may seek civil monetary penalties against the company. The fines can be as high as $10,000 for each day of the violation until it is corrected. In addition, the FDA could seek other regulatory action, including an injunction and/or criminal prosecution.