New Center of Excellence for Regulatory Science proposed by FDA

FDA commissioner Dr. Margaret Hamburg launched a new initiative to innovate regulatory science so that it can keep pace with the evolution of biomedical research.  New pilot and feasibility studies are proposed to investigate early drug safety and efficacy.  In...

Australian TGA adopts ICH M3(R2) Nonclinical Guidance

The Australian TGA has adopted the EU Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals (ICH M3(R2)bb).  The effective date was November 5, 2010. سباق الخيل مباشر    The purpose of this...

New FDA Safety Reporting Portal

On May 24, 2010, the Food and Drug Administration (FDA) and the National Institutes of Health (NIH) launched a new Web site that, when fully developed, will provide a mechanism for the reporting of pre- and post-market safety data to the federal government. ivermectin...

New Comprehensive Website for European Medicines Agency

On 15 July 2010 the European Medicines Agency (EMA) launched a new comprehensive website to address the regulation and safety of drugs (human, veterinary, and herbal) in the European Union.  The site has been completely redesigned to optimize usability for the...