FDA Moves To Implement New GMP Policies

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.

On PharmTech.com this week, coverage of upcoming events continued, experts continued to discuss the use of AI in pharma, and validation in oral solid dosage product production was emphasized.

This week saw predictive modeling, microstructure intelligence, a CAR T-cell safety pause, and major licensing deals reshape pharma manufacturing.

The FDA approves zilganersen, the first disease-modifying Alexander disease therapy, offering rare disease developers a trial design and RNA delivery model.

Robert Holt, PhD, associate director, Pharmaceutical Science, digiM Solution, discusses microstructure intelligence in more detail in part 2 of this preview of the company’s keynote presentation at AAPS PharmSci 360.

Christy Owings, Thermo Fisher, explains clinical trial supply chain risks in Latin America, importer-of-record strategy, AI, and eCOA delays.

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