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Regulatory Focus: Week in Review (26-30 March)

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By Alexander Gaffney

Regulatory Focus is proud to bring you our first-ever 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.

Top News Items

GAO: Medical Device Reviews Taking Longer Despite FDA Meeting Goals

The US Government Accountability Office released a report Thursday (29 March) indicating it found the US Food and Drug Administration (FDA) to be meeting its performance goals for medical device reviews, but that overall medical device review time was trending upward. More »

EU Parliament Refuses to Approve EMA 2010 Spending, 2013 Budget
The European Parliament is refusing to approve of how the European Medicines Agency (EMA) spent its fiscal year 2010 budget—a move that is delaying the approval of EMA's fiscal year 2013 budget, reports PharmaTimesMore »

Analysis: Resubmissions After Third Round of FDA Review Not Worth Effort
An analysis by the Biotechnology Industry Organization (BIO) of 748 new drug applications (NDAs) and biologics license applications (BLAs) shows a nearly 20% increase in the rate of approvals for second-round submissions in response to a first-round complete response letter (CRL). More »

EMA Strengthens Conflict of Interest Policies
The European Medicines Agency (EMA) announced Monday, 26 March, its Management Board has endorsed a proposal from EMA Executive Director Guido Rasi to strengthen conflict of interest policies surrounding its scientific committee members and experts. More »

US News

Guidance and Draft Guidance for Industry

News and Other FDA Information

Congressional Actions

The Courts

Workshops & Meetings

Agency Information Collection Activities; Proposals, Submissions, and Approvals

Warning Letters & Prominent Recalls


EU News

News and Other EMA Information

Scientific Guidelines

Work Instructions, SOPs, and Regulatory and Procedural Guidelines


Global Regulatory News


Other News


Important Studies, Science News and Whitepapers




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