Pathways’ Picks June 1: Brazil GMP Reg, Senate Dx Reforms, FDA Pre-Sub Norms

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ARTICLE SUMMARY:

In this week’s roundup: Brazil’s ANVISA clarified good manufacturing practice certification procedures; the US Senate sets a date to mark up newly introduced legislation to reauthorize user fees and reform diagnostics oversight; FDA opens up final COVID-19 pre-submissions door and considers other “back to normal” steps; a panel meeting on AI skin analyzers; SUNSET rule withdrawn; and updated Saudi clinical trials guidance.

Top Pick

News from Brazil:

Brazil updates GMP rules. A new regulation outlining Brazil ANVISA’s procedures for assessing and granting good manufacturing practice (GMP) certifications to device manufacturers took effect June 1. Device makers must have a current certification (called CBPF) to market Class III and IV devices in Brazil. The new rule is primarily focused on clarifying ANVISA’s GMP expectations, in particular, what documentation is required for facilities based on location and other factors, and what documents are necessary to renew an existing GMP certification. ANVISA is also publishing for the first time its “risk matrix” for evaluating companies’ GMPs. (Links in Portuguese)

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