Matthew Tanner, Author at ResearchAdministrationDigest.com - Reading the industry so you don't have to

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…

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.…

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…

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…

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…

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…

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…

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…

Hug your favorite Veterinary Technician!

Posted on October 15, 2012 by Matthew Tanner |

To celebrate and promote the role of veterinary technicians, the National Association of Veterinary Technicians in America (NAVTA) has proclaimed the third week of October (14th-20th) as National Veterinary Technician…

Select Agent Program Workshop webinar

Posted on October 15, 2012 by Matthew Tanner |

To discuss the new Select Agent and Toxin regulations resulting from a recent biannual review by the CDC and USDA, a Select Agent Program Workshop webinar taking place November 16th,…