What are the Kefauver-Harris amendments?
October 2012 marks 50 years since the passage of the Kefauver-Harris Drug Act of 1962, known less formally as the Kefauver-Harris drug amendments. The bill, named for US Senator Estes Kefauver…
Author: Matthew Tanner
NIH updates for human subjects research
Investigators and research administrators will want to take note of two NIH guide notices that were published in August 2012. NOT-OD-12-129, “Guidance on Changes That Involve Human Subjects in Active…
Misconduct in clinical research
According to a paper recently published in The Proceedings of the National Academy of Sciences, scientific misconduct is the leading cause of retractions. Misconduct means fabrication, falsification and/or plagiarism during any…
NIH–sponsored workshop calls for more detailed reporting in animal studies
A workshop sponsored by NIH’s National Institute of Neurological Disorders and Stroke (NINDS) has produced a set of consensus recommendations to improve the design and reporting of animal studies. The…
Introduction to the Toxics Release Inventory (TRI) for Communities
For those interesed in toxicant research or their effects, a community webinar will be held to explain the Toxic Release Inventory data that the EPA publishes. From the announcement: The…
Including children in research
Discussions about involving children in research usually center on protecting them from harm, and rightly so. Is there such a thing as too much caution? In a recent analysis of…
Pharmacy compounding in research
The current outbreak of fungal meningitis, which has been linked to epidural injections of a contaminated steroid product from the New England Compounding Center, has brought a great deal of…
NICEATM announces release of ICCVAM report on animal occular testing
The NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) announces availability of an Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) test method evaluation report…
Recommended Procedures Regarding the CPSC’s Policy on Animal Testing
The US Consumer Product Safety Commission (CPSC) has created a webpage listing the recommended procedures for testing substances on animals, with procedures listed by the type of test: Acute Toxicity…
Nobel Prize in Physiology or Medicine Awarded
The Nobel Committee awarded this year’s prize in Physiology or Medicine to John Gurdon, of the University of Cambridge, UK and Shinya Yamanka, of the University of Kyoto, Japan for…