Posts tagged Proposed Guidance.
Blogs
2 minute read
Last week both CDER and CDRH released a list of guidance documents they intend to develop or finalize over the next year. However, it is interesting to note that the approach and information provided by each FDA center diverged significantly. CDRH provided details as to the priority of guidances they plan on developing, offered specific metrics they will use to measure success, and opened up a docket to receive stakeholder comments. CDER also provided a list of guidances; however the process to administer comments and specificity on what guidance documents would be prioritized was ...
Blog Editors
Recent Updates
- HHS OIG Issues Favorable Advisory Opinion Regarding Surgical Supply Discounts to Ambulatory Surgery Centers in Exchange for Software Purchases
- Health Care Workplace Violence Legislation Heats Up in 2026
- 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®’