Drugs

More Women Participating in Clinical Trials: Report

FDA principal deputy commissioner Janet Woodcock and two staff from the agency’s Office of Women’s Health say there have been improvements in the representation of women in clinical trials submitted in FDA marketing applications. “We are encouraged by the potential for new strategies to further their representation,” the three write in a Med commentary.

They write that the CDER Drug Trials Snapshots summary for 2019 showed that 72% of clinical trial participants were female. Recently, Drug Trials Snapshots published a five-year summary report of demographic data from pivotal trials for 231 novel drugs approved between 2015 and 2019, showing that overall, females represented 51% of global clinical trial participants and 56% of trial participants from the U.S.

The report discusses efforts FDA has made to address challenges of inclusion in clinical trials. “We are encouraged by improvements in the participation of women in clinical trials in recent years,” it concludes. “We also recognize that representation gaps remain. It is important for all sectors of medical product development to review the lessons learned from changes in clinical trial conduct resulting from the unparalleled challenges presented by the Covid-19 pandemic and identify those that enhance inclusiveness. Inclusion of women, representing diversity in age, race, ethnic, background, socioeconomic status, and comorbid conditions should be at the forefront of collaborative efforts and innovative strategies to bridge gaps in representation.”

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