Posts tagged Biomarker Qualification.
Blogs
less than a minute
On December 11, 2018, the Food and Drug Administrative (“FDA”) issued a draft guidance for comment entitled, “Biomarker Qualification: Evidentiary Framework” (the “Guidance”). The Guidance provides insight regarding standards for biomarker qualification under the 21st Century Cures Act (“Cures Act”).
FDA defines the term “biomarker” as a “characteristic that is measured as an indicator of normal biological processes, pathogenic processes, or responses to an exposure or intervention, including therapeutic interventions.” There are various ...
Blog Editors
Recent Updates
- Telehealth Cliff Averted, for Now (but September Is Six Months Away)
- The End of the Self-Affirmed GRAS Pathway?
- DEA Telemedicine Rules Further Delayed Until (Nearly) 2026
- Gender-Affirming Care Protections Eroded by Recent HHS Guidance and White House Executive Orders
- Important Negotiating Points in Commercial Real Estate Purchase and Sale Contracts Negotiating the Letter of Intent