Drugs

QCARD Can Improve Oncology Submissions

The FDA Oncology Center of Excellence (OCE) is working with the Reagan-Udall Foundation to evaluate essential data elements that could provide a starting point for characterizing the data sources and study design of an early real-world data study proposal. Writing in an FDA Voices online post, OCE associate director for pharmacoepidemiology Donna Rivera and OCE deputy director Paul Kluetz say the Oncology Quality, Characterization, and Assessment of Real-world Data (QCARD) initiative is intended “to improve the quality of initial study proposals and is not an evaluation of the quality of real-world data (RWD) submitted within a regulatory review.”

The QCARD objectives include:

reviewing the published literature, guidelines, and guidances on RWD and dimensions of quality measurement;
engaging stakeholders and obtaining feedback on essential RWD study design elements and data characteristics; and
generating key study and data elements to facilitate the initial review of studies incorporating RWD.

Rivera and Kluetz say insights from the QCARD initiative have informed information requests sent by oncology review teams when they have received RWD study proposals that lack sufficient information. They say OCE is providing example data elements contained in the information requests to share the lessons learned.

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