Drugs

Covid Brought FDA Focus on Real-World Data: Report

The Covid-19 pandemic forced FDA to take a much closer look at the use of real-world data and it will likely play a bigger role in agency drug reviews as it adopts lessons learned from the pandemic. That’s the view in a 10/26 Bloomberg Law report.

“The urgency of the pandemic has propelled U.S. health leaders to use data from sources such as patient medical records and mobile devices to help make decisions in real time,” the article says. “FDA signaled it will further expand use of these sources through the release of two new draft guidances and a partnership to rapidly assess Covid-19 products.”

The post quotes Friends of Cancer Research CEO Jeff Allen that Covid “sort of forced the examination of real-world evidence. Particularly in the early months of Covid-19, there were no clinical trials that were set up so the information had to come from real-life clinical experiences. That quickly transitioned as therapies became available, or different observational cohorts were more formalized.”

The article cites an expanded contract with Aetion to use real-world evidence to study Covid-19 medical products and new draft guidances on data standards and on using electronic health records and medical claims data to make regulatory decisions about drugs.

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

Read more

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