Drugs

Conducting Clinical Trials During Pandemic

FDA has issued an immediately-effective guidance, FDA Guidance on Conduct of Clinical Trials of Medical Products during the Covid-19 Pandemic, to help clinical trial sponsors assure the safety of trial participants, maintain compliance with good clinical practice, and minimize risks to trial integrity during the Covid-19 pandemic. The document says that challenges for conducting clinical trials may arise from quarantines, site closures, travel limitations, interruptions in the supply chain for investigational product, or other considerations if site personnel or trial subjects become infected with Covid-19.

“These challenges may lead to difficulties in meeting protocol-specified procedures, including administering or using the investigational product or adhering to protocol-mandated visits and laboratory/diagnostic testing,” the guidance says. “FDA recognizes that protocol modifications may be required and that there may be unavoidable protocol deviations due to Covid-19 illness and/or Covid-19 control measures.”

The agency says it recognizes that specific control measures in any trial will vary depending on many factors, and provides general considerations to assist sponsors in assuring the safety of trial participants, maintaining compliance with good clinical practice, and minimizing risks to trial integrity.

Gupta Raises Concerns About Overton’s Independence, Ideology

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FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

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FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome