Posts tagged Master Protocols Guidance.
Blogs
6 minute read
On September 28, 2018, the U.S. Food and Drug Administration (FDA) released two draft guidances for industry. The purpose, according to FDA Commissioner Scott Gottlieb, M.D., is to modernize the approach to clinical trial design in efforts to (1) make clinical trials more efficient while maintaining patient safety and (2) increase the amount of information concerning product safety and benefits. The two draft guidances are entitled: “Master Protocols – Efficient Clinical Trial Design Strategies to Expedite Development of Cancer Drugs and Biologics” and “Adaptive ...
Blog Editors
Recent Updates
- Important Negotiating Points in Commercial Real Estate Purchase and Sale Contracts Negotiating the Letter of Intent
- 2025 Picks Up Steam with Increased Scrutiny of Health Care Transactions and Corporate Structures
- HHS Reverses Its Longstanding Policy and Limits Public Participation in Rulemaking
- Sitting Atop a Telehealth Cliff?
- A Regulatory Haze of Uncertainty Continues as the Clock Ticks Toward Phase One of FDA’s LDT Final Rule