Posts tagged Human Cells Tissues and Cellular and Tissue-Based Products (HCT/Ps).
Blogs
2 minute read
On July 20, 2020, the United States Food and Drug Administration (FDA) announced a six-month extension of its enforcement discretion policy for certain regenerative medicine products requiring pre-market review due to the COVID-19 pandemic. Included in a final guidance document entitled, “Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use,” this extension will give manufacturers additional time to determine whether they need to submit an investigational new drug (IND) or marketing ...
Blog Editors
Recent Updates
- DOGE's Attempt to Crowdsource Medicaid Fraud Scrutiny: Is This the Future of Healthcare Fraud Investigations?
- Feds vs. the States: Dr. Mehmet Oz Announces an Investigation Into New York’s Medicaid Program
- U.S. Supreme Court to Weigh Induced Infringement Case Regarding ‘Generic Version of Vascepa®’
- Closer Look at H.R. 7291: What the “GRAS Oversight and Transparency Act” Could Mean for Dietary Supplements
- Diagnostic Imaging Interoperability Request for Information Shines a Spotlight on the Lack of Patient-Centered Longitudinal Health Records