FDA could blacklist foreign manufacturers if inspections flouted
This article was originally published in Clinica
The FDA has threatened to report foreign manufacturers to US customs if they do not comply with agency requirements and do not have their plants ready for an FDA inspection. The agency can include these companies in the Import Alert list, which features companies subject to automatic detention, meaning some or all of their products are barred from entering the US.
You may also be interested in...
The European public assessment report for Kaftrio shows that EU regulators had concerns about whether Vertex’s triple drug combination for cystic fibrosis represented a new treatment paradigm.
Swissmedic says its good manufacturing practice certificates remain valid for longer than companies might assume. Separately, it is giving companies more time to conduct nitrosamine-related risk evaluations.
Stada has appointed a head of digital communications; PGEU elects new chair and vice-chair; and the new UK health claims committee unveils its first members.