Drugs

FDA Wants More Informed Consent Flexibility

FDA says it wants to amend its regulations to implement a provision of the 21^st Century Cures Act and add an exception to informed consent requirements for certain FDA-regulated clinical investigations that present no more than minimal risk to human research participants. If finalized, the proposed rule would allow the Institutional Review Board (IRB) responsible for the review and approval of the research to waive or alter certain elements of informed consent, or to waive the requirement to obtain informed consent entirely, under limited conditions.

To waive or alter informed consent under the proposal would require the IRB to make findings that have been included in a Common Rule waiver provision for minimal research risk for decades, FDA says. The agency says the Common Rule provision has provided appropriate safeguards to protect the rights, safety, and welfare of individuals participating in certain minimal risk research for over 25 years.

FDA says it will withdraw a related 2017 guidance if the proposed rule becomes final. It also is asking for input on the types of minimal risk clinical investigations for which sponsors or investigators would anticipate requesting a waiver or alteration of informed consent from the IRB.

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