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Debate over Drug Patents goes to Supreme Court in India

Posted on March 9, 2012 by Jeffrey Waldin |

The case involves a section of the patent law in India that is designed to prevent companies from receiving new patents by making minor changes to existing drugs, unless those changes significantly improve the effectiveness of the drug. One question…

Using Social Media to Boost Clinical Trial Recruitment

Posted on March 8, 2012 by Matthew Tanner |

Up to 50% of clinical trial sites are unsuccessful in their efforts to enroll participants. Overall, only about 20% of clinical trials meet enrollment timelines. Some companies and advocacy organizations are turning to social media initiatives in hopes of improving…

Public Hearing on FDA Oversight of Research

Posted on March 8, 2012 by Matthew Tanner |

FDA has announced a 2-day public hearing to obtain input on its regulatory oversight of clinical research. The target audience includes industry representatives, investigators, IRBs, professional organizations, advocacy groups, and others involved with clinical trials. Advance registration is required to attend…

Conditional Allele Mouse Planner (CAMP): Software to facilitate the planning and design of breeding strategies involving mice with conditional alleles

Posted on March 8, 2012 by Matthew Tanner |

An online Java-based software tool called CAMP is available to design breeding strategies and predict costs of generating mice with inheritable conditional alleles. Upon running the applet, users can enter genetic information on up to 6 alleles per gender of variable…

GAO Reports – There’s an app for that!

Posted on March 7, 2012 by Roger Wood |

The US Government Accountability Office (GAO) launched a new iPhone/iPad app this week, that links to mobile versions of its reports, congressional testimony, podcasts and videos. For research administrators who like to keep up with new GAO activity, this app…

Revised risk assessment from DHS regarding proposed Kansas animal research facility

Posted on March 6, 2012 by Matthew Tanner |

The DHS (Department of Homeland Security) released a revised “Site-Specific Risk Assessment” (SSRA) of the National Bio and Agro-Defense Facility (NBAF) on March 2nd, 2012. The document is available as an Executive Summary, Volume I, Volume II, and Appendices (Note: these…

Publishers Opposing Federally Mandated Public Access to Research Outputs

Posted on March 6, 2012 by Roger Wood |

Yesterday, March 5th 2012, the Association of American Publishers announced that 81 US publishers are opposing a new bill in both houses of Congress that would mandate all research findings from federally funded projects be publicly accessible within six months…

IOM Releases New Report on Pediatric Studies

Posted on March 5, 2012 by Matthew Tanner |

The Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA) are both up for congressional re-authorization this year. On February 29, 2012, the Institute of Medicine released a study committee report examining these and other pieces of…

Form FDA 1572 Still Valid for Use

Posted on March 5, 2012 by Matthew Tanner |

Federal agencies must periodically apply to the US Office of Management and Budget (OMB) for continued clearance of forms that collect information from the public. The process is intended to ensure that forms are appropriately designed and are not unduly…

US NSF Financial Conflicts of Interest

Posted on March 2, 2012 by Roger Wood |

Just when you thought you were getting a handle on National Institutes of Health’s new FCOI policy… The US National Science Foundation (NSF) is soliciting comment on their proposal to carry out a survey to better understand how NSF grantees…