Aims to develop a cloud-based Global Data Sharing Platform to facilitate data and information sharing between industry and health authorities worldwide.
A look at EUA standards and approvals, unavoidable pitfalls, Operation Warp Speed, FDA’s use of Real-World Evidence, and a slow return to "normalcy".
Chad Landmon, Michelle Divelbiss and Alex Alfano, Axinn, Veltrop & Harkrider LLP's Intellectual Property and Food and Drug Administration Practice Groups01.05.21
Matthew Prokopczyk brings 25 years of experience in the pharmaceutical industry in the areas of quality control, regulatory compliance and quality assurance.
Despite FDA's postponement of most facility inspections, the pharma manufacturing industry should be prepared for heightened scrutiny as this crisis develops.
John J. Carney, Lee H. Rosebush, Susrut A. Carpenter, Andrew M. Serrao, BakerHostetler04.22.20
Temporarily postpones all domestic routine surveillance facility inspections, for-cause inspections will be evaluated and will proceed if mission-critical.