Drugs

FDA Real-World Evidence Framework Explained

As part of the FDA program to use real-world evidence based on real-world data for safety and efficacy decisions involving drugs, demonstration projects will cover data, real-world evidence tools, and real-world evidence study design. CDER Office of Medical Policy director Jacqueline Corrigan-Curray reviewed in a 3/15 Webinar the program elements and activities outlined in a 12/2018 agency strategic framework announcement.

She said FDA is separating real-world data (claims data, electronic health records, patient information) from real-world evidence (benefit/risk information derived from an analysis of real-world data).

The strategic framework, Corrigan-Curray said, covers internal processes, guidances, stakeholder involvement, and pilot projects.

She noted that no single source of real-world data may capture all the available data and thus one of the issues being looked at is how to integrate data from diverse sources. Attempts are being made to integrate collection of real-world data with clinical trials so collection of data is closer to the point of care.

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