Drugs

5 Reps’ Bill Would End Mandatory Animal Testing

Reps. Vern Buchanan (R-FL), Elaine Luria (D-VA), Nancy Mace (R-SC), Mikie Sherrill (D-NJ), and Brendan Boyle (D-PA) have introduced H.R. 2565, the FDA Modernization Act, to lift requirements for animal testing for any new drug development and to enable FDA to require the most effective testing methods, regardless of whether animals are used. The action was praised by Animal Wellness Action, the Center for a Humane Economy, the Michelson Center for Public Policy, and other affiliated organizations.

The bill would allow the pharmaceutical industry to use emerging, superior technologies in nonclinical testing for new drugs, instead of relying solely on animal tests, the groups say. They say the bill is consistent with FDA’s initiative to advance regulatory science.

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