With potentially less flexibility and a simpler calculation on the benefit-risk of approving COVID vaccine boosters, FDA could punt the more challenging questions like whether boosters are needed now and for which populations, along with global equity and public health considerations to the Center for Disease Control and Prevention’s Advisory Committee on Immunization Practices.
All eyes will be on the US Food and Drug Administration and its vaccine advisors this week as they evaluate Pfizer Inc./BioNTech SE’s supplemental application for a third dose of its COVID-19 vaccine amidst ongoing debate at to whether the Biden administration jumped the gun – and the data – in calling for universal booster availability by 20 September.
But it’s the Centers for Disease Control and Prevention that is likely to be forced to make the most difficult and politically
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.
