• Report: New EU Clinical Trials Regulations to Come As Early as Next Week

    • 10 July 2012
    European Commissioner for Health and Consumers John Dalli plans to introduce new clinical trials legislation as early as 17 July 2012, reports Reuters . The legislation, previewed at a 27 June meeting in Washington, DC, is in response to what Dalli referred to as a "decline in clinical research in the EU." The EU has seen a 25% decline in the number of clinical trials conducted in the EU between 2007 and 2011, though Dalli hedged that the decline was not exclusive...
  • Warning Letter Analysis: FDA Cracks Down on Companies With Unregistered Facilities

    • 06 June 2012
    The US Food and Drug Administration (FDA) sent eight warning letters to foreign-based pharmaceutical manufacturers between January 2012 and May 2012 after finding the companies were exporting pharmaceutical products to the US in violation of the Federal Food, Drug and Cosmetic Act . Specifically, the primarily Asian-based companies has failed to register their facilities with FDA, which requires the registrations to exercise oversight over the facilities' manufacturing ...
  • Brazil: Consultation Open on Criteria for Priority Review

    The Public Consultation - CP No. 26 - on proposed new criteria for establishing the priority review for registration of medicines opened on April 20 and comments may be submitted within 30 days. The proposal would grant priority review according to a points system to products that reach at least 10 points. The application for prioritization would have to be made electronically and ANVISA would have 75 days to decide on petitions for priority registration, 90 days fo...
  • US DEA Releases Fee Schedule for Chemical Registrations

    The US Drug Enforcement Administration (DEA), a division of the US Department of Justice (DOJ), released an updated adjustment of the registration and reregistration fees associated with its Diversion Control Program on 13 March. The program is used by DEA to control the manufacture, distribution, dispensing, importation and exportation of controlled substances and List I chemicals. List I chemicals are those deemed to be important in the manufacture of controlled subst...
  • FDA: 99% of Establishment Registrations Now Electronic Post-FDAAA

    The US Food and Drug Administration (FDA) is reporting today via the Federal Register that the overwhelming majority of establishment registrations are now taking place electronically, including initial establishment registrations, foreign registrations and annual registrations. The Food and Drug Administration Amendments Act of 2007 (FDAAA) includes sections 222, 223 and 224, which regulate the registration of establishments under Section 510 of the Federal F...