FDA Policy/General

Califf Plan to Improve Healthcare Outcomes, Equity

FDA commissioner Robert Califf has laid out a six-part action plan to better leverage health technology, data, and capabilities to improve healthcare outcomes and equity. GovCIO Media reports Califf said during the 4/4 Health Datapalooza that there is a need for private and public entities to work together to realign medical capabilities and the way they are strategized and used across society.

His action steps are:

create a better system of evidence generation for decision-making;
revamp the public health information architecture;
close the gap between FDA approval and the appropriate use of products and payments;
aggregate available information in a way that supports consortia driven by patients, their families, caretakers, and clinicians;
consciously create incentives that reduce some optimization and improve assessment of the impact of subsystems on overall outcomes for individuals and populations; and
tackle misinformation and improve education about science.

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