Drugs

Bill to Advance Pregnant/Lactating Women in Trials

Representatives Kathy Castor (D-FL), Brian Fitzpatrick (R-PA), and Lauren Underwood (D-IL) have introduced HR 9487, Advancing Safe Medications for Moms and Babies Act of 2022. The legislation would build upon prior legislation to help better understand the effect of medications on pregnant and lactating women and their infants. “By updating FDA regulations, establishing a national clearinghouse of educational materials, creating a coordinating committee of federal activities, and raising awareness for patients and providers, this legislation will help ensure that moms and babies stay safe and healthy,” the lawmakers say in a release.

The bill would require FDA to harmonize its human subject protection regulations, specifically the Code for Federal Regulations Title 21 parts 50 and 56 with the latest HHS regulations, according to a bill summary. The lawmakers say that the current FDA regulations still contain provisions citing “pregnant women” as a vulnerable category of subjects, which may hinder the participation of these populations in research.

It also would establish a Committee on Research Specific to Pregnant and Lactating Women to provide advice on coordinating federal activities to address gaps in knowledge and research regarding safe and effective therapies for pregnant and lactating women.

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