Drugs

Benefit-Risk Framework Enhancements Coming

FDA says that benefit-risk assessment is a fundamental element of the agency’s drug regulatory decision-making, and both the agency and stakeholders continue to see value in FDA’s Benefit-Risk Framework (BRF) as a tool to support internal agency decision making, improve communication to internal and external stakeholders, and improve transparency in the regulatory decision-making process. A report, “Benefit-Risk Assessment in Drug Regulatory Decision-Making,” says the framework will be enhanced as part of the PDUFA 6 reauthorization. And, it says, the agency will clarify through draft guidance its considerations on benefit-risk assessment through the drug development lifecycle, including premarket and postmarket phases.

“We also look forward to identifying opportunities to enhance the value of the BRF as a communication tool to drug developers, healthcare providers, patients, and others,” the report says, “and to explore potential additional tools that can be used within the qualitative BRF to further support FDA’s benefit-risk assessments.”

The report outlines some of the PDUFA 6 commitments for continued implementation of structured benefit-risk assessment during FY 2018-2022, including participating in a meeting to gather stakeholder input, publishing a draft guidance on benefit-risk assessment for new drugs and biologics, continuing to revise relevant Manuals for Policies and Procedures and Standard Operating Practices and Procedures to incorporate benefit-risk assessment approaches, and conducting a second evaluation of the implementation of the BRF beginning in 2021.

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