Regulatory Focus: Week in Review (21-25 May)

Posted 25 May 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: [14-18 May] [7-11 May] [1-4 May] [23-27 April] [16-20 April]

Top News Items

BREAKING UPDATE: After Setbacks, Senate Passes Amended User Fee Bill
After multiple days of political wrangling and an unexpectedly large number of amendments, the Food and Drug Administration Safety and Innovation Act has been approved in the US Senate in a 96-1 vote.

GHTF Changes Definitions of 'Medical Device' and 'IVD'
The Global Harmonization Task Force (GHTF), an international harmonization body soon to be disbanded, and replaced by the new International Medical Devices Regulators' Forum (IMDRF), has released a final guidance altering how medical devices are defined.

Report: REMS Preventing Companies From Making Generic Medicines
The Food and Drug Administration Amendments Act of 2007 allowed the US Food and Drug Administration to institute Risk Evaluation and Mitigation Strategies (REMS) for products with a high probability of misuse or dangerous side effects.

Health Canada Approves World's First Stem-cell-based Therapy
Canadian regulators have approved the world's first stem-cell-based therapy for a systemic disease, granting Maryland-based Osiris Therapeutics' Prochymal approval for the treatment of graft-versus-host disease (GVHD).

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