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

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

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

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

While a one-stop shop still has its advantages, sponsor companies and CDMOs are starting to see each other not as ...

Pharmaceutical Technology serves as the connection to bio manufacturing and development, featuring regulatory updates and ...

In this episode of the Ask the Expert video series, Susan J. Schniepp, distinguished fellow at Regulatory Compliance ...

In this exclusive Drug Digest video, Deepak Bahl from Roquette and Jagruti Patel from Lonza look at strategies for ...

Following an overhaul at ACIP, the HHS secretary took the advice of the committee’s new members, saying he was acting on guidance that dated back to 1999.

US pharma firms face higher drug costs, delayed launches, and compliance risks from proposed sectoral tariffs, prompting ...

Speedier implementation of the Post-Approval Change Management Protocol is essential for it to have a positive effect on ...

US pharma tariffs may start low and rise, risking drug shortages, higher costs, and pressure on generics amid reshoring push.