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Posted 22 June 2012 | By Alexander Gaffney, RAC
Regulatory Focus is proud to bring you another edition of Week in Review-a recap of the global regulatory news space for the preceding week. We cover news and regulatory intelligence from around the globe and bring it to you in one organized location. If you read just one thing this week, make it Regulatory Focus' Week in Review.
Previous Week in Reviews: [11-15 June] [4-8 June][21-25 May] [14-18 May] [7-11 May] [1-4 May]
FDA User Fee Bill Easily Passes the House, On Pace for July Approval
The Food and Drug Administration Safety and Innovation Act (FDASIA) is set for a vote in the Senate next week after receiving overwhelming approval from the US House of Representatives on 20 June. The user fee legislation would reauthorize and modify a number of existing programs that provide industry funding for activities at the US Food and Drug Administration (FDA) and make a litany of changes at the agency. More »
EMA Releases Final Biosimilar Guidelines
The European Medicines Agency (EMA) has finalized two guidance documents pertaining to medicines containing monoclonal antibodies. The two guidance documents address two different aspects of the development of biosimilar medicines: in vivo clinical testing of medicinal products and aspects related to nonclinical and clinical testing. More »
Researchers: FDA Beats EMA, Health Canada in Drug Approval Times
A recent study published in the New England Journal of Medicine (NEJM) stated that the US Food and Drug Administration (FDA) approved drug products nearly two months faster than its European and Canadian counterparts on average and got products to market first in the majority of cases. After including the total review time in their analysis, investigators said their research "found more proof that the FDA is faster than its peers." More »
MHRA Warns of Counterfeit Medical Devices
The UK's Medicines and Healthcare products Regulatory Agency (MHRA) sent out a warning to physicians and consumers recently regarding the discovery and seizure of several counterfeit medical devices sold through online retailers. The agency said it had seized hundreds of discount-priced devices lacking proper CE safety marking, warnings or instructions for proper use. More »
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This article provides a variety of websites with important information on recent changes to FDA guidances and tables ...