Drugs

FDA Alternative Review Tools ‘Critical’ in Decisions: Study

FDA researchers say the alternative tools used by the agency to evaluate data reliability and integrity, good clinical practice (GCP) compliance, and subject safety during the Covid-19 public health emergency were “critical in informing the agency’s regulatory decisions for marketing applications while mitigating the spread of Covid-19.” Writing in the Journal of the Society for Clinical Data Management, the researchers say their study shows that the remote evaluation of clinical trials from FDA locations was useful in evaluating clinical investigators and sponsor/contract research organization data integrity, subject safety, and clinical trial conduct.

In the future, they say, alternative tools can be complementary to on-site GCP inspections, particularly when travel limitations exist. Also, they write, the tools can be considered to expand the breadth of the inspection coverage.

The researchers reviewed internal agency databases and identified and characterized alternative tools used in place of CDER on-site GCP inspections for FY 2020 and 2021. They report that between 4/13/2020 and 9/30/2021, FDA conducted 77 GCP evaluations using alternative tools. They supported the review of 29 NDAs and 12 BLAs during the public health emergency.

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