Newsletter | July 22, 2025

07.22.25 -- Radiopharmaceuticals: Navigating FDA Guidance And CMC Considerations

FEATURED EDITORIAL

Radiopharmaceuticals: Navigating FDA Guidance And CMC Considerations

The unique nature of radiopharmaceuticals necessitates specialized regulatory considerations, particularly for chemistry, manufacturing, and controls (CMC).

INDUSTRY INSIGHTS

Time, Logistics, And Manufacturing In Autologous Cell Therapy Clinical Trials

Learn how the establishment of effective guidelines and standardization relevant to cell therapy development can help to minimize delays and lead to more positive outcomes.

Hidden Benefits Of Clinical Forecasting And Supply Planning Solutions

Streamline clinical supply chain management with SmartSignals Supplies, reducing errors and inefficiencies from spreadsheet-based forecasting.

Seamless And Risk-Free Regulatory Implementation Of Labeling

Learn how by having a strategy for “core-to-carton” compliance, drug developers can avoid risks for patients and their company.

SOLUTIONS

The Next-Generation Of Clinical Trial Data Management And Operations