FDA Policy/General

FDA Steps to Harmonize with HHS Common Rule

FDA chief medical officer Hilary Marston and Office of Clinical Policy director Ann Meeker-O’Connell say the agency is modernizing its oversight of clinical research and harmonizing with the HHS Common Rule protecting people who participate in research to make clinical trials more efficient and improve information for potential participants. Writing in an FDA Voices post, the two discuss two recently published proposed rules that they say demonstrate the significant progress that has been made toward harmonizing agency human subject protection regulations with the Common Rule for the kinds of research that FDA oversees.

One proposed rule would generally require the use of a single institutional review board for clinical studies with multiple research sites. The second rule would enhance the informed consent process for people considering participating in clinical trials to help them decide whether they should participate in the trial.

The post also says FDA is now working to finalize a previously issued proposed rule to help enable certain minimal-risk clinical investigations for which the informed consent requirement is waived or certain elements of informed consent are waived or altered.

FDA says it will continue to work with federal partners and clinical research stakeholders on harmonization efforts related to protecting clinical trial participants.

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