Regulatory Focus: Week in Review (28 May - 1 June)

Posted 01 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 the 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: [21-25 May] [14-18 May] [7-11 May] [1-4 May] [23-27 April]

Top News Items

House Overwhelmingly Passes User Fee Legislation
The US House of Representatives voted overwhelmingly to support the Food and Drug Administration Reform Act (FDARA), sending the bill to a conference committee for an ultimate merger with the Senate's Food and Drug Administration Safety and Innovation Act (FDASIA).

EMA Releases First Revision to Biosimilar Quality Guidelines Since 2006
The European Medicines Agency (EMA) announced it has released a newly-revised guideline on the quality of biosimilar medicines and is soliciting comments. The 31 May 2012 guidance, Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues, updates a previous guidance released in 2006.

FDA Aims to Accelerate Approval of Breast Cancer Drugs
The US Food and Drug Administration (FDA) released new draft guidance for industry, providing an intended outline for sponsors hoping to utilize an accelerated approval pathway for drug-based preoperative breast cancer treatments.

New EMA-run Website Looks to Boost Adverse Event Reporting Transparency
The European Medicines Agency (EMA) is looking to enhance its transparency measures surrounding the receipt and publication of adverse event reports for all medicines authorized in the European Economic Area through a brand-new website.

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