Naming and labeling questions will likely be resolved with agency actions on pending biosimilar applications.
FDA is planning to issue several additional guidances on biosimilars in the “near future,” Sally Howard, Deputy Commissioner for Policy, Planning, Legislation And Analysis, said. But that policy work is not impacting the agency’s review of pending applications.
In fact, the user fee deadlines for the two biosimilar applications have been publically announced seem to be driving the...
Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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A new pilot aims to take Brazil closer to ‘digital transformation.’
Although the UK Health Research Authority’s initial proposal for simplified informed consent was rejected by stakeholders, it has yielded valuable insights into reducing trial burden and widening access
Ultragenyx said talks with the FDA about a path forward after receiving a CRL for UX111 have been productive despite the recent upheaval at the agency.
Many agency stakeholders believe Vinay Prasad may be forced to change his regulatory approach at least somewhat after receiving a second chance to lead the US FDA's biologics center.
