Monthly FDA Guidance and Regulatory News Review - May 2026
This May 2026 regulatory update highlights multiple guidances issued by the FDA across cell and...
Monthly FDA Guidance and Regulatory News Review - April 2026
This April 2026 regulatory update highlights new policies on biomarker validation, expanded access...
Measuring What Can't Be Seen: How PTSD Clinical Trials Prove a Drug Works
When an oncology drug is tested, the signal is often brutally clear. A tumor either shrinks on a...
The Psychedelic Setback: What MDMA Rejection Taught Drug Developers
In August 2024, the FDA declined to approve MDMA-assisted therapy for post-traumatic stress...
Monthly FDA Guidance and Regulatory News Review - March 2026
March 2026 regulatory updates underscore newly published final and draft guidances focused on...
Monthly FDA Guidance and Regulatory News Review - February 2026
In February 2026, FDA activity included new draft guidances, regulatory initiatives (e.g., PreCheck...
Tackling the Complexities of Advanced Therapies for Neurology
Developing advanced therapies for neurology is often described as a “perfect storm of complexity.”...
The Compound Effect of Specialized Knowledge
In life, specialized knowledge is required when guesswork is not an option.
Monthly FDA Guidance and Regulatory News Review - January 2026
January 2026 regulatory updates underscored evolving AI-focused policies, ongoing scrutiny of...
Rare Disease Development: Navigating Small Populations and Complex Protocols
Each rare disease may affect only a few thousand, or even a few dozen, people worldwide. Yet...