FDA Under DOGE: What Workforce Reductions Mean for the Pharmaceutical Industry
FDA Under DOGE: What Workforce Reductions Mean for the Pharmaceutical Industry
Writing for Human and AI Reviewers: The New Way to File
The rise of automated FDA AI reviewers means mastering the balance between machine-readable data and clear medical storytelling. It is no longer optional—it is the key to avoiding costly filing delays.
How the FDA is speeding up Psychedelic Therapies with National Priority Vouchers
How the FDA is speeding up Psychedelic Therapies with National Priority Vouchers
Ethical Research and the Importance of Quality
This week in the Guardrail: Rigorous quality oversight isn't just a regulatory hurdle; it is the ultimate expression of respect for the safety and dignity of the patient. Read more about Ethical Research and the Importance of Quality in this week’s Guardrail blogpost.
GLP and GCP: How the FDA and EPA Watch Over Science
Two of the most important sets of rules are called GLP and GCP. In 2026, the two main government agencies responsible for these rules, the Food and Drug Administration (FDA) and the Environmental Protection Agency (EPA), are working together more than ever before. Re: FDA & EPA Oversight.