Research Compliance Archives - Page 15 of 29 - ResearchAdministrationDigest.com - Reading the industry so you don't have to

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 index animal was a 10 year 7 month-old Holstein…

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 well-being”. A resource on this scale would be highly valuable…

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 of various databases and data collection projects. It will also…

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 a patient’s own cells. Regenerative Sciences, a Colorado company whose…

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 gold or silver d. Animals that sing off-key e. Animals…

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 regulations, which applies to any clinical investigation submitted to 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 presenters, will focus on issues related to the development of…

WHO releases proposed guidelines for research involving H5N1

Posted on July 27, 2012 by Matthew Tanner |

The World Health Organization (WHO), issued a “Guidance for adoption of appropriate risk control measures to conduct safe research on H5N1 transmission”, available here. The proposed considerations are: 1. Facilities wishing to work with the laboratory-modified H5N1 should critically evaluate…

First Gene Therapy treatment approved in Europe

Posted on July 23, 2012 by Matthew Tanner |

On 19 July 2012, after a second evaluation which involved the adoption of a formal opinion of the Agency’s Committee for Advanced Therapies (CAT), the Committee for Medicinal Products for Human Use (CHMP) concluded that Glybera’s benefits outweigh its risks…

Report provides recomendations on NBAF (National Bio- and Agro-Defense Facility)

Posted on July 19, 2012 by Matthew Tanner |

The Committee on an Analysis of the Requirements and Alternatives for Foreign Animal and Zoonotic Disease Research and Diagnostic Laboratory Capabilities; Board on Agriculture and Natural Resources; Board on Life Sciences; Division on Earth and Life Studies; National Research Council…