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MedTech Europe’s new report on the administrative burden of MDR and IVD regulations. Excerpted from Pathways’ Picks March 19: Dr. Oz Hearing, FDA Office Challenges, China Picks, and More.
The agency has republished its sex-specific guidance, with deletions. Excerpted from Pathways’ Picks April 2: FDA Hit Hard by Layoffs, LDT Regulation is Dead, Global “Reliance” Plan Floated.
FDA authorized its first De Novo in the Trump era. Excerpted from Pathways’ Picks March 26: MDR Reform Input Streams In, Makary Confirmed at FDA, and More.
The CDRH impact of HHS’ Large-Scale HHS Layoffs. Excerpted from Pathways’ Picks April 9: CDRH Fallout, Dr. Oz Confirmed, China and South Korea Innovation Proposals, and More.