User Fees For Biomarker Qualification Might Improve Study Designs
Despite Bob Temple’s assurance that draft enrichment guidance allows companies to exclude biomarker-negative patients, industry asks FDA for more guidance on when they can safely say a biomarker is discriminatory.
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When and how to incorporate marker-negative patients into enriched clinical trials remains undefined for drug companies, which appear accepting of limited indications for marker-positive patients.
Commissioner’s comments were yet another sign that US FDA won’t clear a vaccine ahead of the election, but hours later the president suggests the White House may decline to clear the agency’s new guidance on emergency use authorization standards for COVID-19 vaccines, raising new concerns about political interference in any decisions.
While neither party is likely to make any big policy changes this year, the action from both sides of the aisle indicates politicians still see going after pharma as a winning issue with voters even as polls show voters are focused elsewhere.