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

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 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 ...

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

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

Tariffs on APIs and finished drugs could take effect as early as August 1, with accelerated investigations raising urgency for supply chain planning.

In this episode of the Ask the Expert video series, Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Siegfried Schmitt, PhD, vice president, Technical at Parexel, ...

George Francis Tidmarsh, MD, PhD, founding co-director of Stanford’s Master of Translational Research and Applied Medicine ...