Nine duloxetine recalls since 2024 show why generic drug manufacturers need route-level nitrosamine risk assessment, not end-product testing alone.

FDA approves GSK's bepirovirsen for chronic hepatitis B after a 19% functional cure rate, raising oligonucleotide scale-up stakes for manufacturers.

Ravi Kiran Kaja, PhD, USP, explains what harmonization of extractables and leachables standards looks like in practice.

Jaenisch, Muraru, and Pandey discuss new skills for QC and regulatory teams, plus patient trust, as new approach methodologies reshape pharma.

AI accountability, faster FDA pathways, rare disease CMC review, and next-gen GLP-1 formulation lead this week’s PharmTech roundup.

Jaenisch, Muraru, and Pandey join PharmTech's Cole to discuss FDA's generative AI paper, ARPA-H's SURPASS trials, and AI accountability.

Richard Jaenisch explains what FDA's real-world use case database means for CMC and quality teams navigating NAMs.

Richard Jaenisch examines whether FDA's NAM pathway truly shortens drug pipelines or just shifts the evidentiary burden elsewhere.