Addressing human interventions to reduce their impact on contamination requires addressing broader considerations than ...

Many companies face FDA complete response letters due to ongoing chemistry, manufacturing, and controls, or CMC, and ...

The agency has given a positive recommendation for a change in the gas propellant in Trixeo Aerosphere and Riltrava ...

Cross-functional trade compliance planning is critical as pharma braces for broad 232 tariffs and shifting United States-China-India supply dynamics.