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Regulatory Focus: Week in Review (23-27 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: [16-20 April] [9-13 April] [2-6 April] [26-30 March]

Top News Items

User Fee Act Passes Senate Panel While Tensions Escalate in the House
The US Senate's Health, Education, Labor and Pensions (HELP) Committee passed a collection of user fee acts in a bill called the Food and Drug Administration Safety and Innovation Act (FDASIA), while members of the House of Representatives remained at odds over various aspects of proposed user fee legislation. More »

China Probe Into Chromium-Laced Capsules Escalates
Chinese regulatory authorities have announced the expansion of a probe into pharmaceutical capsules illicitly laced with Chromium, saying they have arrested nine more people, detained a further 45 and seized more than 77 million capsules, reports ReutersMore »

Internal FDA Reports Slams EU Regulation of Medical Devices
The US Food and Drug Administration (FDA) has lambasted Europe's review process for medical devices in an unreleased internal report, claiming the failure of some devices to obtain FDA approval despite being approved in Europe is an "affirmation of the US medical device approval process," reports the Minneapolis Star Tribune. More »

EMA Electronic Submission Gateway Goes Live for Human Medicines
The European Medicines Agency (EMA) is announcing its eSubmission Gateway—the "electronic submission channel" for submitting electronic common technical documents (eCTDs) to EMA—is now up and running for all applicants for centralized marketing authorizations. More »

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