This month, we binge on the behavior of bacteria, lean into the latest chemical reductants, and shine a light on federal requirements for clinical trial data.
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The Food and Drug Administration (FDA) and the National Institutes of Health (NIH) have the authority to regulate clinical trial reporting requirements. Despite this authority, FDA and NIH have scantly enforced this area since the requirements were created by Congress in 2007, hindering the clinical trial transparency promised to the public. However, there may be a shift in the lackadaisical enforcement over such reporting. On April 28, 2021, Acting FDA Commissioner Janet Woodcock, M.D., announced that that the agency had sent more than 40 pre-notices to sponsors of clinical trials for failing to submit required clinical trial results to ClinicalTrials.gov. Notably, a Notice of Noncompliance was issued for the first time.
FDA Ups the Ante and Sends First Notice of Noncompliance for Failure to Submit Clinical Trial Results Thursday, May 6, 2021
The Food and Drug Administration (FDA) and the National Institutes of Health (NIH) have the authority to regulate clinical trial reporting requirements. Despite this authority, FDA and NIH have scantly enforced this area since the requirements were created by Congress in 2007, hindering the clinical trial transparency promised to the public. However, there may be a shift in the lackadaisical enforcement over such reporting. On April 28, 2021, Acting FDA Commissioner Janet Woodcock, M.D., announced that that the agency had sent more than 40 pre-notices to sponsors of clinical trials for failing to submit required clinical trial results to ClinicalTrials.gov. Notably, a Notice of Noncompliance was issued for the first time.
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In March, Iowa Title Guaranty issued a March 17, 2021 Bulletin modifying its policies regarding residential prelien notices, i.e., Commencement of Work Notices and Preliminary Notices, on residential projects.
About Iowa Title Guaranty
Iowa Title Guaranty is Iowa’s exclusive title coverage provider, offering lenders and owners low-cost title coverage for Iowa real property. Among other things, on residential real estate sales, Iowa Title Guaranty provides assurance to a lender that the lender’s lien is valid and in the desired lien position. Iowa’s abstract and attorney title opinion system is thorough, but on rare occasions, title defects arise. Iowa Title Guaranty offers lender coverage to protect the lender’s interest from covered title defects.
WASHINGTON, D.C. – The U.S. Department of Energy (DOE) today issued a Preliminary Notice of Violation (PNOV) to Fluor-BWXT Portsmouth LLC (FBP) for violations