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
- DOJ’s Final Rule on Bulk Data Transfers: The First 180 Days
- California Governor Signs SB 351, Strengthening the State’s Corporate Practice of Medicine Doctrine
- No Remuneration Plus No "But-For" Causation (Between an Alleged Kickback and Claims Submitted to the Government) Means No FCA Violation, District Court Says
- Novel Lawsuits Allege AI Chatbots Encouraged Minors’ Suicides, Mental Health Trauma: Considerations for Stakeholders
- DOJ Creates Civil Division Enforcement & Affirmative Litigation Branch: Implications for Health Care and Beyond