Drugs

ICH Meetings to Update on Good Clinical Practice

An International Council for Harmonization (ICH) expert working group is holding two meetings (5/18-19) to provide an update on the progress to revise its ICH E6 good clinical practice guideline. Last month, an ICH management committee released a draft version of the guideline (see earlier story). ICH says it determined that sharing the draft of the principles “would facilitate transparency and common understanding. Although public comments are not requested at this time, once the updated ICH E6 guideline achieves Step 2 of the ICH guidance development process, public input will be invited and considered.”

The meetings are intended to discuss the work-in-progress to develop principles and annexes for the guideline “that are intended to be responsive across clinical trial types and settings and remain relevant as technology and methodologies advance,” the group says. They will also discuss plans and approaches to update the guideline in general, and it will include presentations from stakeholders on their vision for clinical trial design and conduct, it says.

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