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  • FDA Creates Program to Boost Regulatory Science, Speed Drug Development

    The US Food and Drug Administration (FDA) is announcing the launch of a new program that it hopes will help to advance clinical trial design and endpoints to boost regulatory science and facilitate expedited drug development. The program, which FDA is calling the Drug Development Tools (DDTs) Qualification Program, is being run by FDA's Center for Drug Evaluation and Research (CDER). The Center sees the program as "a mechanism for formal review by CDER to qualify drug de...
  • Judge Orders FDA To Remove Antibiotics from Animal Feed

    A federal judge ruled this week that The US Food and Drug Administration (FDA) must either make plans to withdraw approval for the use of most antibiotics in animal feed or withdraw approval for non-therapeutic use of those antibiotics, reports Reuters . The 22 March ruling by US Magistrate Judge Theodore Katz comes after mounting concerns about antibiotic resistance and emerging so-called "superbugs" being seen as a threat to human health. Katz noted FDA had recently ...
  • Animal Import Troubles Squeeze UK Clinical Research

    • 19 March 2012
    Clinical research in the UK is at risk because private companies are refusing to import animals after being pressured by animal rights activists, reports Reuters . Researchers and scientists are claiming many ferries and airlines are refusing to import many commonly-used research animals, including mice and rats. "Threats to the carriage of these animals will slow down the progress of essential and life-saving biomedical research," said scientists from the Medical Rese...
  • FDA Proposes New Regulations for Unapproved Animal Drug Residues in Imported Food

    The US Food and Drug Administration (FDA) released a new proposed regulation on Wednesday, 25 January that aims to provide a stable pathway for persons requesting the import of food items containing residues of animal drugs that are unapproved in the US. The proposed regulation -  Import Tolerances for Residues of Unapproved New Animal Drugs in Food   - is the final outstanding action FDA needs to take to fully implement the Animal Drug Availability Act of 1...
  • Report, Guideline on Target Animal Batch Safety Test for Vaccines Released by EMA

    The European Medicines Agency (EMA) released a report and a guideline on 23 January about target animal batch safety tests (TABST) for veterinary vaccines. EMA has been trying to implement a waiver system for TABST requirements for marketing authorization holders (MAHs), but has received significant pushback from companies claiming that the waivers aren't worth their time. The report highlights their concerns, while the guideline revises the data requirements necessar...
  • US Bioterrorism Countermeasures Run in to Regulatory, Ethical Hurdles

    The United States has been working to develop countermeasures to potential biological terror attacks on U.S. soil and abroad.  In response to the anthrax attacks of 2001 and later simulations by the National Security Council and Johns Hopkins University that estimated that a coordinated smallpox attack could kill up to one million U.S. citizens, the Department of Defense started the Transformational Medical Technologies Initiative in 2006 to develop what it refers to...