Drugs

Senators Want Animal Testing Info

A bipartisan group of nine senators led by Sen. Rand Paul (R-KY) is asking FDA for information on the specific steps the agency is taking to update its animal testing regulations and the timeline for the implementation of a revised regulatory framework under the FDA Modernization Act 2.0. In an 11/16 letter, the senators say the legislation removes the FDA mandate for animal testing of all new drug candidates and allows an applicant to use methods other than animal testing to establish a drug’s safety and effectiveness.

As a result of the approval of the FDA Modernization Act 2.0, the letter says, FDA’s regulations on animal testing no longer conform to applicable law. For example, it says, federal regulations governing the submission of IND applications require that IND amendments should be supported by the results of animal toxicology studies or other human studies as appropriate. Also, it says, regulations governing the IND’s investigator’s brochure call for a summary of the pharmacological and toxicological effects of the drug in animals and, to the extent known, in humans.

“These and other regulatory provisions no longer reflect the full scope of the governing statute and should therefore be updated as expeditiously as possible,” the senators say.

Joining Paul in the request were Sens. Cory Booker (D-NJ), Mike Braun (R-IN), Angus King (I-ME), Roger Marshall (R-KS), Tim Kaine (D-VA), John Kennedy (R-LA), Ben Ray Luján (D-NM), and Eric Schmitt (R-MO).

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