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 ...

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

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

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

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

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

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

The company will build a multi-billion-dollar drug manufacturing center in Virginia that will focus on chronic diseases, as ...

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.

PMMI, The Association for Packaging and Processing Technologies, has announced some of the unique features being made ...