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Latest news on the fungal meningitis outbreak

The total count of CNS and joint infections related to the multistate fungal meningitis outbreak has risen to 247, with 19 deaths reported (including 8 in Tennessee, the hardest hit[…]

Stem cell trials in the news

Recent news reports highlight two interesting stem cell trials involving children, one completed and one just getting underway. Researchers at the Sutter Neuroscience Institute in[…]

Approval pathway proposed for significant drug combinations

Earlier this month, US Congressional Representatives Brian Bilbray (R-CA, Carolyn Maloney (D-NY) and Rosa DeLauro (D-CT) introduced House Resolution 6502, the Life-Threatening Diseases Compassion through Combination[…]

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[…]

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[…]

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,[…]

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?[…]

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[…]

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[…]

Perceived impact of funding on clinical research quality

A recent Scientific American Guest Blog post by Jalees Rehman, MD, explored whether the source of funding affects clinical research quality. Many members of the research community[…]