Drugs

Issues Raised on Proposed IRB Consent Waiver

Public Citizen says that unless an FDA proposed rule on institutional review board (IRB) waiver or alteration of informed consent for minimal risk clinical investigations is clarified, it could increase the risks to human subjects while undermining their right to informed consent before being enrolled in clinical trials. The group’s comment letter says Public Citizen is “deeply concerned that once FDA finalizes the proposed rule, clinical investigators inappropriately will seek, and IRBs inappropriately will grant, waivers of informed consent for clinical investigations that involve greater than minimal risk to subjects…. It is imperative that when the agency finalizes the proposed rule, it simultaneously issues detailed guidance that clearly describes the types of research that would and would not qualify for an IRB waiver of informed consent under FDA’s human subject protection regulations. The guidance should include specific examples of each type of clinical investigation….”

AdvaMed says that the proposed rule appropriately implements requirements in the 21^st Century Cures Act. The association also says FDA should provide clarification or advisory text for sponsors, investigators, and IRBs to carefully consider the specific data elements to be collected as part of the research to determine the applicability of HIPAA Privacy Rule requirements.

The Association of Clinical Research Organizations (ACRO) says future harmonization with the fifth criterion of the Common Rule is unnecessary, but may be helpful. The association also advises that instances where sponsors would anticipate requesting a waiver or alteration of informed consent from the IRB for FDA-regulated minimal risk clinical investigations seem rare.

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