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
- New Proposed Federal Legislation Takes Aim at Concerns Regarding Perceived “Looting” of Health Care Systems by Private Equity Investors
- Podcast: The Future of Laboratory Testing Just Got a Little Clearer - FDA's Final Rule on LDTs – Diagnosing Health Care
- How Does the End of Chevron Deference Change the Relationship Between the Health Care Industry, Federal Regulators, and Congress?
- Podcast: Down Goes Chevron: A 40-Year Precedent Overturned by the Supreme Court – Diagnosing Health Care
- Thoughts: AB 3129 Expands Its Reach