The FDA’s long-awaited draft guidance on decentralized trials (DCT) is finally out and industry has been abuzz with discussion. Experts feel it has arrived at a pivotal moment for clinical research and does many things right, but some recommendations may draw industry pushback.
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The top challenges named by sites in a recent WCG Clinical survey — staffing, recruitment, trial complexity and others — are not new but are increasingly impacting sites’ ability to take on new trials, the survey says.
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The FDA published three guidance documents for sponsors last week, providing advice on statistical analysis, endpoint selection and electronic data submission.
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Two new draft guidances released by the FDA share the agency’s recommendations on designing effective pediatric trials and dealing with various issues inherent to developing pediatric therapies.
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Starting in September, the European Medicines Agency (EMA) will begin gradually resuming its efforts to openly share clinical trial data for medical products, the agency reported.
The European Medicines Agency (EMA) is seeking public comment on its transparency rules and protection of personal and commercially confidential data submitted to its clinical trials database.
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CenterWatch analyzes data in its drug intelligence database to provide advance notice of clinical trials expected to enter the next phase
of clinical development soon. Contact information is provided for follow-up. Sponsors/CROs: to list an upcoming trial here, contact
Leslie Ramsey, 703.538.7661, lramsey@wcgclinical.com.
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The following is a sampling of FDA regulatory actions taken during the previous month, compiled from CenterWatch and third-party sources, including the FDA and company press releases. For more information on FDA approvals, visit centerwatch.com/fda-approved-drugs.
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