Maintaining GxP with a 21 CFR Part 11-Compliant Tracking System

Ravi Kiran Kaja, PhD, explains how USP’s industry-wide initiative aims to build confidence in trace-level extractables and leachables results.

FDA final guidance defines when companion app output counts as drug labeling and when device-connected or standalone apps belong in prescribing information.

Science, circularity, regulation, and technology are reshaping how the industry develops packaging for medicines.

Panelists on PharmTech AI Pulse Check debate SURPASS, a new digital-twin trial program, regulatory acceptance, and the data-cleanup burden it will create.

Roche-Hansoh, Merck KGaA-Silence, and Lilly-METiS deals show how ADCs, siRNA, and lipid nanoparticles reshape demands on CMC and manufacturing teams.

Germany is home to several prominent pharma companies and more than 1000 innovative biotechs.

Boyang Wang of Immortal Dragons explains how FDA's Expedited IND Pilot and QRIs could compress sequential first-in-human steps as China's Decree 818 raises the pace.

The deadline to comment on FDA's generative AI paper is Oct 19, 2026. We explain why professionals in pharma manufacturing should weigh in.