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Regulatory Focus: Week in Review (30 April - 4 May)

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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. We cover the 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: [23-27 April] [16-20 April] [9-13 April] [2-6 April] [26-30 March]

Top News Items

France: New Agency to Soon Replace AFSSAPS (Regulatory Focus)
France has created a new agency, the National Agency for the Safety of Medicines and Health Products (MSNA), to replace its current regulatory agency, Afssaps.

FDA Announces Additional Restrictions on Disqualified Clinical Investigators (Regulatory Focus)
The US Food and Drug Administration (FDA) is announcing changes to its rules governing how clinical investigators are disqualified, vastly expanding the scope of the disqualification.

EU Looks to Tighten Medical Device Safety With Implant Registry (Regulatory Focus)
The European Parliament is actively looking to pass legislation that would make it easier for regulatory authorities to track both medical devices and patients implanted with medical devices, reports Fierce Medical Devices.

AHRQ Looking to Establish Registry of Patient Registries (Regulatory Focus)
The US Agency for Healthcare Research and Quality (AHRQ), the federal agency charged with improving how healthcare dollars are spent, is announcing its intention to launch a registry of patient registries modeled after of its ClinicalTrials.gov website.


Regulatory Focus Features


US News

FDA Information: Medical Devices

FDA Information: Pharmaceutical and Biologics

FDA Information: Other News

Other US News

Legislative Update

The Courts

Compliance and Safety Issues

Workshops & Meetings

Deals and Acquisitions


EU News

Editor’s Note: EMA was closed 1 May and did not release any guidance 1-3 May

Regulation and Guidance

EMA Information

Other EU News

Meetings and Workshops


Global Regulatory News


Important Studies, Whitepapers and Research


Regulatory Reads


Other News and Interesting Reads




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