The US Food and Drug Administration is in a position to deny approval of drugs studied in hospitals and medical centers affiliated with the People’s Liberation Army under existing regulations and should consider doing so, a bipartisan group of US House members told Commissioner Robert Califf in a 19 August letter.
Key Takeaways
-
House Select Committee on the Chinese Communist Party outlines concerns with US biopharma companies' clinical trial collaborations with hospitals in China affiliated with the military in 19 August letter.
-
The letter, which aims to put pressure on biopharma companies to avoid military hospital partnerships, specifically cites clinical trials by Eli Lilly and Pfizer as examples of the practice
“The FDA has previously declined to approve oncology treatments based on clinical trial data solely produced from clinical trial sites in China, suggesting the FDA should also impose similar scrutiny to
Read the full article – start your free trial today!
Join thousands of industry professionals who rely on Pink Sheet for daily insights
- Start your 7-day free trial
- Explore trusted news, analysis, and insights
- Access comprehensive global coverage
- Enjoy instant access – no credit card required
Already a subscriber?