Combination Products Raise Manufacturing Challenges

The agency issued a direct final rule that supports the use of innovative testing methods to limit the use of animals and maintain existing safety standards.

The FDA approves Inluriyo-Verzenio combo for ESR1-mutated breast cancer; EMBER-3 data double PFS, with supply chain and diagnostics implications for manufacturers.

This week, the FDA opened applications for its Expedited IND Pilot, quality experts presented at the PDA/FDA Joint Regulatory Conference, and Hovione expanded its spray drying capacity.

Andrea K. Kerrigan, FDA, outlines how validation, data integrity, and QRM determine whether digital tools and AI strengthen or undermine CGMP compliance.

PDA/FDA 2026 session maps the GMP audit lifecycle, root cause to CAPA closure, plus a local vs. above-site decision framework and two case studies.

Lori Dingledine, QC Director Microbiological Control and GTIC Operations at Genentech, provided input on the regulations surrounding raw material manufacturing and use for ATMPs in a presentation at the 2026 PDA/FDA Joint Regulatory Conference.

2026 approvals, clinical data, and licensing deals are advancing subcutaneous biologics, reducing patient burden, and reshaping biopharma drug strategy.

AI can turn medical device risk management into a continuous signal.