Drugs

FDA’s New Real-World Evidence Strategic Framework

FDA has released a 2019 strategic framework under which it will continue to advance opportunities to use real-world data to improve regulatory decisions. FDA commissioner Scott Gottlieb says the strategic framework “is aimed at leveraging information gathered from patients and the medical community to inform and shape FDA’s decisions across our drug and biologic development efforts. This strategic framework will form a cornerstone of our efforts to advance the use of these tools. In the coming months, we’ll advance other new initiatives to better leverage real-world data and real-world evidence in our programs.”

According to Gottlieb, the framework will be a roadmap for more fully incorporating real-world data and real-world evidence into the regulatory paradigm. It outlines a number of important real-world evidence efforts to explore the potential for using real-world evidence to help support approval of new indications for approved drugs or to support or satisfy post-approval study requirements.

“Potential advances to be explored under the framework,” he writes, “include the use of real-world data and real-world evidence to help support revisions to labeling about drug and biologic product effectiveness or safety, including adding or modifying an indication, such as a change in dose, dose regimen, or route of administration, adding a new population, or adding comparative effectiveness or safety information.”

The framework reportedly involves establishment of demonstration projects and stakeholder engagement, as well as use of internal processes to bring senior leadership input into the evaluation of real-world evidence and promote shared learning and consistency in applying the framework.

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