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

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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. 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 »


Regulatory Focus Features


US News

Regulation and Guidance

FDA Information

Other US News

Legislative Update

The Courts

Workshops & Meetings

Compliance Issues


EU News

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

Regulation and Guidance

EMA Information

Other EU News

Meetings and Workshops


Global Regulatory News


Important Studies, Whitepapers and Research


Other News and Interesting Reads




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