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IACUC Administrators’ Best Practices Meeting

Posted on October 26, 2012 by Matthew Tanner |

The IACUC Administrators Association (IAA) will be presenting a Best Practices Meeting on November 8-9, 2012 in Boston, MA. This 2-day meeting is for IACUC staff and animal program operations personnel to present and share best practices in the humane…

NIH Commercialization Assistance Program for SBIR and STTR Phase II Awardees

Posted on October 22, 2012 by Jeffrey Waldin | 0 Comments

If the purpose of university technology transfer is to maximize the benefits of public and private investment in research, those offices cannot rely exclusively on traditional licensing efforts. Some technologies lend themselves to a more entrepreneurial approach, where the total…

Texas IRB shut down for significant violations of 21 CFR 56

Posted on October 19, 2012 by Matthew Tanner |

In a warning letter dated September 24, 2012, FDA says the Texas Applied Biomedical Services Research Review Committee (TABS RRC) “significantly violated…21 CFR Part 56”. The agency is withholding approval of all new trials reviewed by TABS RRC, and the IRB…

Parents need more help understanding phase 1 trials

Posted on October 19, 2012 by Matthew Tanner |

A study published this week in the Journal of Clinical Oncology suggests that physicians need to work on their presentation of phase 1 trials to parents of children with cancer. Dr. Eric Kodish and colleagues recorded 85 consent discussions at children’s…

Latest news on the fungal meningitis outbreak

Posted on October 18, 2012 by Matthew Tanner |

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 state). How could this have happened? According to an article posted this morning on industry news site PharmPro,…

You decide, should H5N1 be considered a select agent?

Posted on October 17, 2012 by Matthew Tanner |

The government needs your input, according to the Department of Health and Human Services and the Centers for Disease Control and Prevention. In a federal register posting, the CDC is requesting public comments regarding the highly pathogenic avian influenza (HPAI) H5N1 viruses…

Stem cell trials in the news

Posted on October 16, 2012 by Matthew Tanner |

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 Sacramento, CA, in conjunction with CBR (Cord Blood Registry) – which bills itself as the…

Modifications to the NIH/CDC Select Agent Regulations

Posted on October 16, 2012 by Matthew Tanner |

Summary: HHS/NIH/CDC is amending and republishing the list of select agents and toxins and their governing regulations that have the potential to pose a severe threat to human health. This is the current final rule determined by a review that…

Approval pathway proposed for significant drug combinations

Posted on October 15, 2012 by Matthew Tanner |

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 Therapy Act of 2012. The intent of this legislation is to create a new “significant drug…

Modifications to the USDA/APHIS Select Agent List and use rules

Posted on October 15, 2012 by Matthew Tanner |

Summary: USDA/APHIS is amending and republishing the list of select agents and toxins and their governing regulations that have the potential to pose a severe threat to animal or plant health, or to animal or plant products. This is…