Drugs

Guidance on Using Electronic Records, Claims Data in RWD

FDA has published a draft guidance, Real-World Data: Assessing Electronic Health Records and Medical Claims Data to Support Regulatory Decision-Making for Drug and Biological Products, to provide sponsors, researchers, and other interested stakeholders with considerations when proposing to use electronic health records (EHRs) or medical claims data in clinical studies to support a regulatory decision on effectiveness or safety. The document covers these topics relating to the use of EHRs and medical claims data to support regulatory decisions:

· selection of data sources that appropriately address the study question and sufficiently characterize study populations, exposure(s), outcome(s) of interest, and key covariates;

· development and validation of study design elements; and

· data provenance and quality during data accrual, data curation, and into the final study-specific dataset.

The guidance does not provide recommendations on the choice of study design or type of statistical analysis, FDA says, and does not endorse any type of data source or study methodology.

The guidance contents are Introduction; Background; General Considerations; Data Sources; Study Design Elements; Data Quality During Data Accrual, Curation, and Transformation Into the Final Study-Specific Dataset; Documentation of the QA/QC Plan; Documentation of the Data Management Process; Glossary; and References.

The guidance was issued in part to fulfill a requirement in the 21^st Century Cures Act for FDA to issue guidance on using real-world evidence in regulatory decision-making.

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