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Cooperative Patent Classification Scheme for USPTO and EPO Officially Launched

Posted on January 10, 2013 by Jeffrey Waldin |

The newly launched Cooperative Patent Classification (CPC) is the result of over two years joint effort between the USPTO and EPO to create a scheme that combines the best practices of both offices. In their statements, both USPTO Director David…

New Clinical Trials Drugs and Biologics Guidance Documents

Posted on January 8, 2013 by Matthew Tanner |

Two new “Guidance for Industry and Investigators” clinical trials documents are available from the FDA. They include: Safety Reporting Requirements for INDs and BA/BE Studies This guidance is intended to help sponsors and investigators comply with the requirements for investigational…

Federal Select Agent Program Workshops – 2012 Webcast Information

Posted on January 8, 2013 by Matthew Tanner |

Recently, the Federal Select Agent Program hosted a workshop to review the newest Select Agent regulations overseen by APHIS, the CDC and the FBI. The Training section of the Select Agent website has been updated with the Workshop Notice, Agenda and Presentations. …

A Guide to the Behavior & Enrichment of Laboratory Rodents

Posted on January 8, 2013 by Matthew Tanner |

From Charles River: November 8, 2012 – A well-designed behavioral husbandry program should accommodate the innate physiological and behavioral needs of the laboratory animals involved. A Guide to the Behavior & Enrichment of Laboratory Rodents, authored by behavior and enrichment…

NIH Approves Boston Univ. Infectious Diseases Lab

Posted on January 3, 2013 by Roger Wood |

After a final risk assessment and consideration of public comment, NIH published its final approval notice for a new state-of-the-art National Biocontainment Laboratory – the National Emerging Infectious Diseases Laboratories (NEIDL). Final State approval processes remain to be completed now.…

Update: US Federal Research Funding

Posted on January 2, 2013 by Roger Wood |

The state of federal research funding in the US remains tenuous at best. Late Tuesday night, the US House of Representatives passed HR 8, the American Taxpayer Relief Act of 2012, which had been delivered to the House from the…

Ethics, Scientific Merit Review, and Harm-Benefit Analysis in Animal Research

Posted on December 26, 2012 by Matthew Tanner |

PRIM&R will be hosting a Webinar on January 30, 2013, 1:00-2:30 PM ET by Jerry Collins, PhD and Ernest Prentice, PhD, entitled “Ethics, Scientific Merit Review, and Harm-Benefit Analysis in Animal Research” Conducting research with animals is essential to the advancement of…

USDA Publishes Final Rule to Help Facilities Be Better Prepared for Emergencies

Posted on December 26, 2012 by Matthew Tanner |

From the USDA: Contact: Andre Bell (301) 851-4059 Joelle Hayden (301) 851-4040 WASHINGTON, Dec. 21, 2012–The U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) is amending its Animal Welfare Act (AWA) regulations to require all licensed…

Draft Guidance for Industry: Preclinical Assessment of Investigational Cellular and Gene Therapy Products; Availability

Posted on December 26, 2012 by Matthew Tanner |

From the FDA: The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled “Guidance for Industry: Preclinical Assessment of Investigational Cellular and Gene Therapy Products,” dated November 2012. The draft guidance document provides sponsors and…

FDA and Health Canada announce first simultaneous review and approval of a veterinary drug product

Posted on December 20, 2012 by Matthew Tanner |

From the FDA on December 12, 2012: The U.S. Food and Drug Administration’s Center for Veterinary Medicine (CVM), in cooperation with Health Canada’s Veterinary Drugs Directorate (VDD), announced today the first simultaneous review and approval of a veterinary drug application…