Drugs

Covid Symptoms in Clinical Trials Final Guidance

FDA has published an immediately effective new final guidance, Assessing Covid-19-Related Symptoms in Outpatient Adult and Adolescent Subjects in Clinical Trials of Drugs and Biological Products for Covid-19 Prevention or Treatment, to give sponsors and investigators considerations for approaches on how common Covid-19-related symptoms can be measured and analyzed in clinical trials evaluating drugs or biological products to prevent or treat Covid-19 in outpatient adults or adolescents. The document supersedes a final guidance with the same name issued in 9/2020.

The guidance also provides a set of common Covid-19-related symptoms as an example as well as an approach to their measurement for use in clinical trials. It is not intended for development programs evaluating products to treat or prevent post-infectious Covid-19 conditions in children and adults, or development programs for preventive vaccines.

The guidance does not address considerations for clinical trial design other than those about the measurement and analysis of Covid-19-related symptoms among outpatients, FDA says. Also, considerations for patients with Covid-19 who require hospitalization are outside the guidance’s scope.

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