Monthly FDA Guidance and Regulatory News Review - September 2026
This September 2026 regulatory update focuses on FDA’s new guidance on neonatal parenteral...
Posts about
Regulatory Submissions
Monthly FDA Guidance and Regulatory News Review - August 2026
This August 2026 regulatory update focuses on the FDA finalizing three guidances addressing formal...
Monthly FDA Guidance and Regulatory News Review - July 2026
This July 2026 regulatory update focuses on the FDA finalizing six guidances that addresses...
Monthly FDA Guidance and Regulatory News Review - June 2026
This June 2026 regulatory update focuses on advancing innovative drug development through updated...
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...