FDA Policy/General

FDA Marks Office of Women’s Health 30th Anniversary

Marking the 30th anniversary of the establishment of the FDA Office of Women’s Health (OWH), FDA commissioner Robert Califf and associate commissioner for women’s health Kaveeta Vasisht write in an online post that OWH has been “at the forefront of ensuring that the unique health needs of women are prioritized through a multifaceted approach that encompasses policy, research, education, and outreach.” In a discussion of those four approaches, Califf and Vasisht cover:

agency funding for over 450 research projects;
promotion of diversity and inclusion of women in clinical trials;
agency championing of better health outcomes on conditions that disproportionately, differently, or uniquely affect women;
support for the OWH Research Fellowship Program that promotes research collaborations among FDA experts, research fellows, and OWH to address critical regulatory science knowledge gaps;
free public educational opportunities on women’s health and FDA-regulated products; and
the Knowledge and News on Women’s Health initiative that leverages high-impact messaging to deliver information on important health topics to educate women on their risk of disease and complications and how to prevent and manage health conditions.

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