News

Latest News | 25 March 2013

Cangene's Botulism Antitoxin Approved by FDA, Giving Animal Rule Pathway Another Victory

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The US Food and Drug Administration (FDA) announced on 22 March 2013 the approval of Cangene Corporation's Botulism Antitoxin Heptavalent (A, B, C, D, E, F, G, Equine), the seventh product approved Read More...

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Latest News | 19 March 2013

Changes Needed to Allow Pediatric Testing of Medical Countermeasures, Report Says

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A new report published by the Presidential Commission for the Study of Bioethical Issues calls for the US government to put into place a modified framework that will allow for researchers to conduct Read More...

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Latest News | 12 February 2013

Could Cangene's Botulism Antitoxin Become the Seventh Product Approved under the Animal Rule?

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The so-called Animal Rule pathway, a regulatory mechanism meant to allow companies to skirt the ethical issues inherent in testing products intended to treat or prevent the effects of dangerous Read More...

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Latest News | 23 January 2013

NIH Committee Calls for Dramatic Reduction in Use of Chimps, Raising Hurdles for Animal Rule

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A new report just published by the National Institutes of Health (NIH) has called for the eventual phase out of the use of most chimpanzees in NIH-supported or –sponsored research, saying through the Read More...

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Latest News | 11 January 2013

After Six Years, Botulism Antitoxin Prepares for FDA Animal Rule Review

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The US Food and Drug Administration (FDA), which recently cleared two drugs using a unique regulatory pathway aimed at facilitating the development and approval of medical countermeasures and Read More...

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Latest News | 17 December 2012

In First for Animal Rule Pathway, FDA Approves GSK's Raxibacumab

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US pharmaceutical regulators have granted approval to GlaxoSmithKline's raxibacumab, a monoclonal antibody that is among the only products—and the first biologic product—to be approved through the US Read More...

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Latest News | 28 June 2012

Presidential Commission Looking to Study Ethical Issues of Animal Rule in Pediatric Populations

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A Presidential Commission in charge of studying bioethics wants to know: what are the ethical issues associated with studying medical countermeasures in children?In a 28 June Federal Register posting, Read More...

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Latest News | 15 June 2012

FDA Looks to Support Animal Rule With New GLP Training Program

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How do you ensure regulatory compliance in the world's most dangerous laboratory environments? The US Food and Drug Administration (FDA) wants to know, and is proposing to put money behind an Read More...

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Latest News | 30 April 2012

J&J Antibiotic Approved Via 'Animal Rule' Pathway

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After being backed by a US Food and Drug Administration (FDA) advisory committee, life sciences manufacturer Johnson & Johnson (J&J) has won FDA approval for Levaquin (levofloxacin), an antibiotic Read More...

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Latest News | 5 April 2012

FDA Close to Approving J&J Drug Via Animal Rule Pathway

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Advisers from the US Food and Drug Administration (FDA) are backing a Levaquin, a drug candidate manufactured by Johnson & Johnson, despite the drug not undergoing human clinical trials, reports Read More...

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