Drugs

PhRMA Changes for Data Committee Guide

Pharmaceutical Research and Manufacturers of America (PhRMA) says it recognizes that data monitoring committees (DMCs) have a unique role in clinical trial oversight and can provide specialized expertise to evaluate emerging safety and efficacy data for ongoing clinical trials. Responding to an FDA draft guidance on the use of data monitoring committees in clinical trials, PhRMA makes these general recommendations:

revise the guidance to acknowledge that DMC charters may reference the protocol and statistical analysis plan as including the schedule and basis of planned interim analyses, rather than including this information directly in the DMC charter;
update the guidance to clarify that sponsors need not adjust the significance level of the final analysis to account for multiplicity specifically because the DMC is provided with access to accumulating, unblinded summary efficacy data in the context of their routine assessment of the emerging benefit/risk profile of the study drug;
revise the guidance to address unique and practical considerations for the use of DMCs in early-stage trials;
remove discussions of “adaptation committees” from the draft;
clarify what entities FDA considers to be “all parties involved” in determining whether actions dictated by the adaptation plan are considered reasonable by all parties involved; and
consider including examples where it would be appropriate for a sponsor to make changes to trial design and would be doing so based on knowledge of the treatment arm assignment.

PhRMA also provides specific comments on the draft.

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