Regulatory Focus: Week in Review (4-8 June)

Posted 08 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: [28 May-1 June] [21-25 May] [14-18 May] [7-11 May] [1-4 May] [23-27 April]

Top News Items

Judge: Regulatory Inspection Report Can Form Basis of Class Action Lawsuit
On Monday, 4 June a federal appeals court ruled a securities fraud class action lawsuit could proceed against pharmaceutical manufacturer KV Pharmaceuticals for purportedly causing $1.5 billion in shareholder losses after first misleading the US Food and Drug Administration (FDA) about manufacturing problems at a facility and later shutting down the facility's manufacturing operations.

New FDA Guidance Could See Patients Obtaining Quicker Access to Experimental Therapies
The US Food and Drug Administration's (FDA) newly released draft guidance on neoadjuvant breast cancer treatments has the potential to radically change the existing pathway through which patients with aggressive early-stage breast cancer can obtain treatment, say experts.

EMA Looks Back on a Tough Year as it Forges Ahead
Kent Woods wants stakeholders to know he understands: 2011 was a tough year. As Chair of the European Medicines Agency's (EMA) Management Board and head of the UK's Medicines and Healthcare products Regulatory Agency (MHRA), Woods has had a front seat to many of Europe's most difficult regulatory problems.

Reforms to FDA's Medical Device Disagreement Policies Needed, Says Report
A new government report looking at scientific disagreements within the US Food and Drug Administration's (FDA) medical device branch recommends a number of changes at the agency after a series of high-profile disagreements between staff brought on unwanted media attention.

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