FDA Guides On Biosimilars And Controlled Correspondence
Q&A Documents Seek To Address Common Queries
Updated Q&A guidance on the US biosimilars pathway has been published by the US FDA, as well as a Q&A guidance document on quality-related controlled correspondence.
You may also be interested in...
After 180 Life Sciences recently struck a deal with Korea’s Celltrion to support its work in repurposing off-patent biologics, CEO Jim Woody speaks to Generics Bulletin about what the collaboration means for the company and its next steps.
A continuing lack of legal certainty continues to plague suppliers to the Northern Ireland market despite the latest proposals from the EU Commission, UK and European off-patent industry leaders Mark Samuels and Adrian van den Hoven tell Generics Bulletin.
With multiple US biosimilar applications held up by the FDA’s inability to conduct necessary inspections in the context of the COVID-19 pandemic, the agency tells Generics Bulletin that it is “actively working” on a solution.