Drugs

Finalized Informed Consent Guidance Analyzed

Three Ropes & Gray attorneys say an FDA 8/15 final guidance on informed consent “illustrates a continuing trend toward modernization of clinical research through adoption of risk-based positions that attempt to reduce administrative burden while maintaining protections for human subjects.” Their online Alert also says FDA gives increased guidance on how new technologies can be incorporated into the informed consent process and the interaction between FDA regulations and other bodies of law, including HIPAA and standards for financial conflicts of interest.

“Sponsors, institutions, institutional review boards (IRB), and investigators can expect additional changes to FDA’s informed consent regulations and guidance upon FDA issuing the final rule on harmonization with the HHS Common Rule (Federal Policy for the Protection of Human Subjects) and the final rule on waiver of informed consent,” the attorneys conclude.

The analysis concentrates on areas in which FDA has modified its position from that in a 2014 draft guidance. Key concepts it covers are:

streamlining IRB review of informed consent forms;
communicating new information to subjects;
investigator conflicts of interest;
template/model informed consent forms;
sponsor-subject interactions; and
enrollment in multiple investigations.

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