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Tenth Meeting Set for Presidential Bioethics Commission

Posted on July 17, 2012 by Matthew Tanner |

The next meeting of the Presidential Commission for the Study of Bioethical Issues will be held August 1-2, 2012, in Washington, DC. The discussion will focus on ethical issues related to pediatric research and human genome sequencing. For more information,…

USDA Announces Availability Of Biotechnology Regulatory Petitions

Posted on July 16, 2012 by Matthew Tanner |

Under an improved regulatory process announced by APHIS in November 2011, the Agency is providing the opportunity for earlier input from the public on petitions for deregulation of genetically-engineered (GE) plants. The Agency is also committing to working closely with…

Webinar by OLAW: Housing Laboratory Rodents According to the 8th Edition of the Guide

Posted on July 16, 2012 by Matthew Tanner |

From OLAW: Housing Laboratory Rodents According to the 8th Edition of the Guide: OLAW Webinar, July 19 Join us for a special 2 hr webinar: “Housing Laboratory Rodents According to the 8th Edition of the Guide” on July 19, 2012…

Transcript of “Grants Policy and Congruence” Webinar now Available

Posted on July 16, 2012 by Matthew Tanner |

From OLAW: Transcript of “Grants Policy and Congruence” Webinar now Available A transcript of the OLAW Webinar, “Grants Policy and Congruence”, held June 7, 2012 has been posted on the OLAW website. The transcript includes additional submitted questions and comments…

AEs, SAEs, and UPIRTSOs…Oh My!

Posted on July 13, 2012 by Matthew Tanner |

Numerous terms, all with subtle differences in meaning, are used to refer to the undesirable occurrences commonly referred to as adverse events. An article in the July edition of the Journal of Clinical Research Best Practices provides a helpful overview of…

Research Animal Procedures Rise in the UK

Posted on July 12, 2012 by Matthew Tanner |

According to the Home Office (UK), animals’ subjected to scientific procedures rose again for the second year, up 2% in 2011 (up 3% in 2010). This amounted to 3.79 million procedures last year. The statistics for 2011 were just released…

Controversial Influenza Papers Published

Posted on July 10, 2012 by Matthew Tanner |

Last week, the second of two controversial papers were published announcing mutations that make the H5N1 Influenza A virus more highly transmissible between ferrets (Herfst et al. and Imai et al.) Both articles alter the H5N1 virus by site-directed mutagenesis,…

Unnecessary Procedures Add Costs and Complexity to Clinical Trial Protocols

Posted on July 5, 2012 by Matthew Tanner |

A study by Medidata Solutions suggests that up to 20% of clinical trial budgets go to pay for procedures that are not directly related to trial endpoints. These additional procedures, which add up to about US$1 million per trial, add…

Regulatory Updates from FDA and OHRP

Posted on June 18, 2012 by Matthew Tanner |

FDA is currently seeking public comments regarding its Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable. The guidance was published in 2006 and is due to expire in 2013. Comments…

DSMBs: Are They Working As Intended?

Posted on June 12, 2012 by Matthew Tanner |

An article by Matthew Herper of Forbes.com raises questions about the independence of data safety monitoring boards (DSMBs), and the potential for trials of promising drugs to be stopped too early.