Timeline is the most pessimistic public projection to date, but still incredibly fast. Clinical trial patients on placebo could be contacted and offered the vaccine after an EUA is granted.
Assuming favorable advisory committee results, the US Food and Drug Administration could issue emergency use authorizations for the Pfizer Inc./BioNTech SE and Moderna, Inc. coronavirus vaccines before Christmas.
Center for Biologics Evaluation and Research Director Peter Marks said 3 December that the agency would need only a few more days to complete its assessment of the applications and
European companies, in particular small and midsize enterprises, spin-offs and start-ups have a hard time expanding within the single market “because of a complex regulatory framework that is perceived as slow and burdensome,” according to the European Commission.
Brensocatib, Insmed's investigational treatment for non-cystic fibrosis bronchiectasis, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.
Industry will fight hard to prevent other states or the federal government from adopting measures similar to Arkansas' law preventing PBMs from owning pharmacies.
