US FDA confirms biosimilars regulation meeting dates
This article was originally published in SRA
The US Food and Drug Administration has formally announced that it will hold a two-day public hearing to gather feedback from stakeholders on specific issues and challenges associated with the implementation of the Biologics Price Competition and Innovation Act of 20091-3.
You may also be interested in...
Bayer has failed to convince the European Medicines Agency that its marketing authorization application for finerenone should be fast-tracked through the EU's centralized review process. There were other successes, though, although Janssen is keeping us guessing over its MAA for amivantamab. These and other developments relating to the agency's accelerated assessment mechanism are logged in this latest update to the Pink Sheet's EU accelerated assessment tracker.
A number of companies have sought to convince the European Medicine Agency that their drug merits a fast-track regulatory review.
While the US and EU regulators seem less than keen on the data package offered to date on COVID-19 Vaccine AstraZeneca, Latin American countries are moving quickly to follow the UK in backing the cost-effective and more-easily deliverable option.