FDA Policy/General

FDA Reports Progress in Clinical Trial Diversity

FDA acting associate commissioner for special medical programs Janice Soreth, who is now chairing the FDA Safety and Innovation Act (FDASIA) Section 907 steering committee to increase clinical trial diversity, says progress has been made on nearly all of the action items the agency needed to take. Writing in an FDA Voice blog post, she says the 2012 FDASIA legislation required the agency to develop an action plan based on a report examining the extent to which various demographic groups were included in clinical trials and their outcomes reported in labeling for medical products for which applications were submitted to the agency. Some 27 separate actions were identified in three priority areas — improving data quality, encouraging greater clinical trial participation, and ensuring more data transparency — she says.

As examples of the progress being made, Soreth cites release of a draft guidance on evaluation and reporting of race and ethnicity data and updates being made to a guidance on collecting race and ethnicity data in clinical trials, Drug Trials Snapshots posted for 75 products, and efforts to raise clinical trial awareness.

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