Vetter’s decades of experience as a contract manufacturer providing fill & finish for injectable drugs helps deliver results for both large and small companies.
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
Independently evaluates certain antibody tests, including antibody tests that were not the subject of an EUA or pre-EUA, and those that were under FDA review
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, BakerHostetler05.05.20