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

Maintaining IRB Membership Documentation

Posted on August 13, 2012 by Matthew Tanner |

Warning letters issued by FDA in recent months highlight the importance of documentation in IRB operations. Although written procedures are required by regulation, they are not sufficient by themselves. As…

World Stem Cell Summit set for December 2012

Posted on August 10, 2012 by Matthew Tanner |

The 8th annual World Stem Cell Summit will be held December 3-5 in West Palm Beach, FL. The event will include a variety of sessions and workshops of interest to IRBs,…

Final Report on the BSE Epidemiological Investigation

Posted on August 7, 2012 by Matthew Tanner |

The USDA released its final report on the epidemiological investigation of a dairy cow from California that tested positive for bovine spongiform encephalopathy (BSE) in April 2012. From the executive summary:…

The promise and pitfalls of big data in healthcare

Posted on August 2, 2012 by Matthew Tanner |

An editorial in The Atlantic examines the challenges of creating a so-called unified health database to “collect in one searchable repository all of the parameters that measure or could conceivably reflect human…

CMS creates new data office

Posted on August 2, 2012 by Matthew Tanner |

The US Centers for Medicare and Medicaid Services (CMS) recently announced the creation of a new Office of Information Products and Data Analysis. The new office will take over management…

Court affirms FDA can regulate autologous stem cell therapies

Posted on August 2, 2012 by Matthew Tanner |

A recent US District Court decision puts the FDA in a better position to impose order on the growing market for stem cell therapies that attempt to treat disease using…

FDA Minor Species

Posted on July 31, 2012 by Matthew Tanner |

Do you know the definition of an FDA Minor Species? Take the test: a. Animals under 2 ft tall b. Animals that cannot drive or drink c. Animals that dig for…

FDA to collect information on financial disclosure requirements for clinical investigators

Posted on July 31, 2012 by Matthew Tanner |

FDA is currently seeking public comments regarding the recordkeeping burden of compliance with 21 CFR 54. Investigators and research sponsors both have specific obligations under this section of the FDA…

FDA to host Pediatric Medical Devices Workshop

Posted on July 31, 2012 by Matthew Tanner |

FDA’s Office of Orphan Products Development recently announced a public educational workshop to be held September 24, 2012 in Silver Spring, MD. The workshop, which will feature FDA and non-FDA-affiliated…

House subcommittee votes to cut DHHS budget, defund AHRQ

Posted on July 27, 2012 by Matthew Tanner |

The US Department of Health and Human Services budget would be cut by $1.3B, and funding for the Agency for Healthcare Research and Quality would be totally eliminated by a…