Drugs

Shift to Include Pregnant Women in Trials: FDA

FDA is pushing for a “major paradigm shift” to move the clinical development community from “systemic exclusion to the inclusion” of pregnant and breastfeeding women in clinical studies. Writing in an online FDA Voices post, officials say it is time to give this patient population needed data about the safety or effectiveness of drugs used during pregnancy. And international regulators are also on the same page.

“Developing a roadmap for change, through international cooperation and harmonization, will take much care, consideration, and communication between all stakeholders,” the post says. "Despite persistent challenges, there is strong interest from the international regulatory community to continue the momentum in this important area of women’s health. The FDA intends to display leadership in such efforts with women, health care professionals, industry, and public health experts.”

The agency has also been participating on HHS’ Task Force on Research Specific to Pregnant and Lactating Women. In 2018, the task force issued a report with 15 recommendations on the research and development of safe therapeutics for pregnant and breastfeeding women, the FDA officials say, adding that an implementation plan was released in 2020.

FDA’s Office of Women’s Health recently funded projects that include the development of an artificial-intelligence virtual pregnant woman modeling suite to support regulatory decisions; model-informed drug passage into breast milk; and assessment of real world use of pharmaceuticals among pregnant and lactating women, according to the post. That office is also funding a pregnancy treatment repository as part of CURE ID. “Health care providers from all over the world can access the platform via the web or mobile app to share and communicate real-world information about the use of existing drugs in new ways (repurposing) — including in pregnant patients to treat cancer and infectious diseases such as Covid-19,” the officials say.

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