Drugs

HHS Pulls Fetal Tissue Research Funds

HHS says it will not further renew a contract with the University of California San Francisco (UCSF) for research involving human fetal tissue from elective abortions.

A department statement says, “Promoting the dignity of human life from conception to natural death is one of the very top priorities of President Trump’s administration.” It says a HHS audit and review of all department-funded research involving human fetal tissue from elective abortions “helped inform the policy process that led to the administration’s decision to let the contract with UCSF expire and to discontinue intramural research, research conducted within the National Institutes of Health, involving the use of human fetal tissue from elective abortion. Intramural research that requires new acquisition of fetal tissue from elective abortions will not be conducted.”

The statement says that in 12/2018 HHS announced a $20 million funding opportunity for research to develop, demonstrate, and validate experimental models that do not rely on human fetal tissue from elective abortions. “HHS is committed to providing additional funding to support the development and validation of alternative models,” 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