Posts tagged Evidentiary Framework.
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On December 11, 2018, the Food and Drug Administrative (“FDA”) issued a draft guidance for comment entitled, “Biomarker Qualification: Evidentiary Framework” (the “Guidance”).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 ...
Back to Health Law Advisor Blog
Recent Updates
- Comment Period Closes on California OHCA’s Proposed Emergency Regulations Expanding Private Equity, Hedge Fund, and MSO Reporting in Health Care Transactions
- DOJ Revises Justice Manual on Non-Binding Guidance and Qui Tam Dismissals: Practical Considerations
- Additional SBA Crackdown on Pandemic-Era Fraud Leads to Program and Loan Suspensions, Possible FCA Enforcement
- Federal Regulatory Views on Cybersecurity and AI Amidst a Growing Threat Landscape
- Remote Monitoring Services Under the 2027 PFS Proposed Rule: Epstein Becker Green Submits Comments to CMS