SynthID Bio: Watermarking AI-Designed Proteins
SynthID Bio embeds hidden watermarks in AI-designed proteins. See how Google DeepMind’s tool could strengthen biosecurity and what pharma R&D should do next.
FDA Expedited IND Pilot Targets Faster First-In-Human Trials
The FDA’s Expedited IND Pilot introduces rolling review and sponsor-QRI partnerships to accelerate Phase I first-in-human trials while retaining regulatory oversight.
FDA Non-Animal Testing Policy Expands Nonclinical Options
FDA non-animal testing policy expands the regulatory role of nonclinical methods and introduces 25 NAM use cases for pharma development teams.
Overton FDA Hearing Tests Scientific Independence
Heidi Overton's FDA confirmation hearing exposed sweeping advisory committee cuts, tobacco industry ties, and unclear stances on vaccines and mifepristone policy.
The FDA Rare Disease Framework Initiative Explained
The FDA Rare Disease Framework Initiative aims to make rare disease drug review more consistent. Explore the six commitments and what sponsors should do now.
CRA-CRC Training for Closing the Sponsor-Site Gap
CRA-CRC training can rebuild sponsor-site trust that remote monitoring weakened. Find out what a 2026 study found and how clinical teams can act on it.