Regulatory Focus™ > News Articles > Regulatory Focus: Week in Review (9-13 April)

Regulatory Focus: Week in Review (9-13 April)

Posted 13 April 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. If you read just one thing this week, make it Regulatory Focus' Week in Review.

Previous Week in Reviews: [2-6 April] [26-30 March]

Top News Items

User Fees Could Be In Peril in Partisan Congress, Says Report
A Bloomberg Government study contends a partisan Congress seeking to make changes to the US Food and Drug Administration (FDA) and the user fee legislation that funds it could put the entire package of user fee legislation in jeopardy. More »

Hamburg Calls for New Authority, Strengthened Anti-Counterfeit Laws
US Food and Drug Administration (FDA) Commissioner Margaret Hamburg said in a statement she believes existing pharmaceutical anti-counterfeiting laws are grossly inadequate to deter illicit activity, saying counterfeiters deserve "more severe consequences."  More »

Report: India Boosting Ability to Regulate Clinical Trials
India's regulatory authorities are boosting their ability to enforce regulatory guidelines after years of heightened requirements, reports Outsourcing Pharma. More »

EMA Releases New Biosimilar Q&A Guidance
The European Medicines Agency (EMA) has published a new guidance document that brings together in a single place a number of regulatory and procedural questions on biosimilars. More »

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[Note: The EMA Was On Easter Break For Much of the Preceding Week.]

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