Drugs

Stakeholder Comments on Real-World Data Guidance

IQVIA says it appreciates the FDA effort to provide guidance on the use of registry data to support regulatory decision-making for drug and biological products and the agency’s conceptual approach to defining multiple key terms. The firm’s 2/25 letter commented on an FDA draft guidance, Real-World Data: Assessing Registries to Support Regulatory Decision-Making for Drug and Biological Products. IQVIA provides comments and recommendations about data standardization and terminology, along with line-by-line specific comments.

The comment submitted by the Real-World Evidence Alliance commends FDA for issuing the guidance and says it agrees with the agency’s recognition that registry data can be useful in regulatory decision-making. The alliance says it advocates for policies that will (1) advance FDA’s real-world evidence (RWE) framework; (2) encourage the use of RWE to better understand treatment effects in underrepresented populations; (3) enhance opportunities for RWE organizations to consult with the agency, and (4) increase communication on generation and use of RWE.

The Biotechnology Innovation Organization offers “overarching comments” on collaborating with registry holders/partners, the scope of the guidance (types of registries), and harmonization of RWE guidance. It also provides specific line-by-line comments.

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