Drugs

Clinical Trial Challenges from Covid-19: Q & A

FDA has issued an updated guidance entitled “Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic.” The document has an appendix on common questions and answers. It was issued earlier in the month because the agency recognizes that the Covid-19 pandemic may impact medical product clinical trials. “For example, challenges may arise from quarantines, site closures, travel limitations, interruptions to the supply chain for the investigational product, or other considerations if site personnel or trial subjects become infected with SARS-CoV-2, the virus that causes Covid-19,” the agency says.

Clinical trial protocol modifications may be required, FDA says, and that there may be “unavoidable protocol deviations” due to Covid-19. The guidance outlines general considerations to assist sponsors in assuring the safety of trial participants, maintaining compliance with good clinical practice, and minimizing risks to a trialֺ’s integrity. The new appendix further explains those considerations by responding to related questions the agency has received. Issues addressed include submitting protocol amendments, documenting protocol deviations, initiating virtual clinical trial visits for monitoring patients, making changes to ship investigational products directly to patients, and obtaining and documenting informed consent from patients in isolation due to Covid-19.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

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