Drugs

Update on FDA Real-World Evidence Activities

FDA commissioner Robert Califf says the agency “is already capable of reviewing submissions that include or rely entirely on RWD (real-world data). Enabling advanced data analytics, including RWD, is also incorporated in FDA’s information technology strategy for 2024-2027.” Writing in an FDA Voices Catching Up with Califf column, he says that supporting robust data infrastructure, developing new methods and analytical tools, and integrating RWE (real-world evidence) with traditional clinical trial evidence will require collaboration across the clinical care, research, and technology sectors, in addition to the direct involvement of patients.

“To help in this context,” Califf writes, “FDA is supporting research (or demonstration) projects that seek to improve the quality of RWD and RWE. Strengthening systems for generating and gathering new and better data and studying those data to provide reliable evidence to inform and improve the many decisions we make as consumers, patients, families, clinicians, and regulators, is key.”

The article refers to a series of FDA guidances to help advance RWE and especially these three recent guidances:

using real-world evidence to support regulatory decision-making for medical devices;
assessing registries to support regulatory decision-making for drugs and biological products; and
data standards for drug and biological product submissions containing real-world data.

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