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The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
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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]
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The US Food and Drug Administration's (FDA) newly released draft guidance on neoadjuvant breast cancer treatments has the potential to radically change the existing pathway through which patients with aggressive early-stage breast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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Tags: Regulatory News, Links, Week in Review, Latest News, regulatory
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This article provides a variety of websites with important information on recent changes to FDA guidances and tables ...