Research Compliance Archives - Page 10 of 29 - ResearchAdministrationDigest.com - Reading the industry so you don't have to

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…

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, 2012, from 9 AM to 5 PM (EST). This event…

What are the Kefauver-Harris amendments?

Posted on October 15, 2012 by Matthew Tanner |

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 of Tennessee and US Representative Oren Harris of Arkansas, amended…

NIH updates for human subjects research

Posted on October 12, 2012 by Matthew Tanner |

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 Awards and That Will Require Prior NIH Approval” NIH approval…