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Regulatory Focus: Week in Review (2-6 April)

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By Alexander Gaffney

Regulatory Focus is proud to bring you 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.

Missed last week's Week in Review? You can find it here.

Top News Items

Proposal Would Overhaul FDA Accelerated Approval Pathway
A new piece of legislation released in discussion draft form by the Senate Health, Education, Labor and Pensions Committee aims to "overhaul" the US Food and Drug Administration (FDA) Accelerated Approval pathway, reports The Hill. More »

EMA's Abadie Resigns as Chair of CHMP
The European Medicines Agency (EMA) announced 4 April that effective immediately, Eric Abadie, chair of the Committee for Medicinal Products for Human Use (CHMP), was resigning from his position.  More »

New FDA Program to Boost Regulatory Science, Speed Drug Development
The US Food and Drug Administration (FDA) announced the launch of a new program intended to advance clinical trial design and endpoints to boost regulatory science and facilitate expedited drug development. More »

Global Global API Inspection Scheme Ramps Up, Seeks New Members
The participants in an active pharmaceutical ingredient (API) inspection program involving many of the world's premiere global regulatory bodies recently announced the intent to standardize the inspection schemes of its member nations and advance "administrative simplification." More »

United States News

Guidance and Draft Guidance for Industry

FDA Information

Other US News

Congressional Actions and Political News

The Courts

Workshops & Meetings

Agency Information Collection Activities; Proposals, Submissions, and Approvals

Warning Letters & Prominent Recalls

European News

News and Other EMA Information

Work Instructions, SOPs, and Regulatory and Procedural Guidelines

Meetings and Workshops

Global Regulatory News

Other News and Interesting Reads

Important Studies, Whitepapers and Research




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