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The agency has cleared the first digital wellness software development kit. Excerpted from Pathways’ Picks September 11: Harmonization Progress, Brazil Regulation, and Novel Software Sign-Off.
EU launches Reference Labs for testing select high -risk diagnostics. Excerpted from Pathways’ Picks September 24: Diagnostics Picks, AI Airlock Applications, HTA Guide, and More.
The agency has cleared the first digital wellness software development kit. Excerpted from Pathways’ Picks September 11: Harmonization Progress, Brazil Regulation, and Novel Software Sign-Off.
The new fiscal year brings a planned reorganization to the agency. Excerpted from Pathways’ Picks October 2: A New Year at FDA, China and US Guidance Docs, and More.