Drugs

Pregnancy Safety Study Workshop Planned

FDA and Duke-Margolis Center for Health Policy are holding a 9/18-19 two-day public workshop to discuss pregnancy safety studies. The workshop is one of FDA’s continuing efforts to enhance postapproval pregnancy safety studies, “capitalizing on the increased availability of population-based healthcare data and advances in methods to study the benefits and risks of treatments,” according to a new post on the agency’s Web site. It also notes that one of the user fee program’s commitments is to “develop a framework that describes how to optimally use data from postapproval pregnancy studies to identify and evaluate safety signals that provide useful and timely information in product labeling for prescribers and patients,” which will be discussed during the workshop later this month.

In the post, CDER director Patrizia Cavazzoni noted that about about 50% of pregnant people use at least one prescription medication at some point during their pregnancy. “Postapproval pregnancy safety studies (or studies that focus on medication use after approval) can help guide clinical practice and provide useful information for product labeling,” she said. “To achieve this, the medical community needs to improve the quality of pregnancy safety studies so that they yield as much relevant information as possible.” A draft guidance on the topic was released in 2019.

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