Regulatory Focus: Week in Review (9-13 July)
| Posted: 13 July 2012
By Alexander Gaffney
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.
Top News Items
New EU Clinical Trials Regulations to Come As Early as Next Week
European Commissioner for Health and Consumers John Dalli plans to introduce new clinical trials legislation as early as 17 July, reports Reuters.
Obama Signs FDA User Fee Bill Into Law
US President Barack Obama signed the Food and Drug Administration Safety and Innovation Act (FDASIA) into law on 9 July 2012.
Clock Starts Ticking on Issuance of FDA's Social Media Guidance
Included in the Food and Drug Administration Safety and Innovation Act (FDASIA), recently signed into law by President Barack Obama, is a provision mandating that FDA issue social media guidance no later than 9 July 2014.
FDA Enacts New Class-wide REMS Policies for Opioids
The US Food and Drug Administration (FDA) announced the approval of a new class-wide Risk Evaluation and Mitigation Strategy (REMS) for the most potent opioid products on the market, saying in a statement that the new policies are meant to balance patient access and safety measures to improve the safe use of the products.
Regulatory Focus Features
[Editor’s Note: During the Month of July 2012, all Regulatory Focus Articles Are Accessible at No Charge
Pharmaceutical and Biologics
Other US News
Compliance and Safety Issues
Workshops & Meetings
Regulation and Guidance
Other EU News
Global Regulatory News
Important Studies, Whitepapers and Research
Other News and Interesting Reads