05.09.25 -- PDG-FDA Town Hall Notes — DSCSA Readiness Is At Hand

This panel discussion explores the intricate challenges in transitioning cell therapy processes from research to Good Manufacturing Practice compliance.

Learn more about a flexible freeze container that maintains package integrity after freezing at -86 °C. (-123 °F) through its durable design, minimizing product loss due to package failure.

The willingness to seek expert support from Rescue CROs when clinical trials face critical challenges is not a sign of weakness but a demonstration of accountability and commitment to excellence.

To address a life-threatening complication of immunotherapy in hematologic malignancies, a U.S. biotech company developed a novel compound.

Explore innovative digital workflow designed specifically for Legally Authorized Representative (LAR) to help overcome the challenges of complex documentation and data management issues.

Explore the landscape of dermatological drug development through a comprehensive framework for rational early-phase dermatological trials, centered around five foundational pillars.

Learn seven of the critical factors for choosing an oncology-focused CRO that enable sponsors to identify partners aligning with their clinical research objectives.

A Mobile Clinical Suite (MCS) proved to be the solution that Syneos Health needed to resolve their Phase 1 study trial challenges with comprehensive eye exams.

Navigate the intricate regulatory landscape with knowledge that can help you move your CRISPR therapies quickly and efficiently through clinical trials.