Drugs

Bill Could End Animal Testing Mandates

Sens. Rand Paul (R-KY) and Cory Booker (D-NJ) have introduced the FDA Modernization Act to end animal testing mandates. Kentucky’s ABC36 TV news says the bill “would end an outdated FDA mandate that experimental drugs must be tested on animals before they are used on humans in clinical trials.”

The measure would not ban animal testing outright, but would allow the option for drug sponsors to use alternative methods when they are suitable.

“The FDA Modernization Act would accelerate innovation and get effective drugs to market more quickly by cutting red tape that is not supported by current science,” Paul said. “It would also prevent the needless suffering and death of animal test subjects, which is something I think both Republicans and Democrats can agree needs to end.”

“Thanks to modern scientific innovation,” Booker said, “the use of animal toxicity testing for experimental drugs has become increasingly obsolete. This legislation will eliminate unnecessary suffering for countless animals when scientifically reliable alternative testing methods are available.”

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