Podcast: Non-binding Guidance: Real-World Evidence in Drug Development and FDA Submissions
This week, the U.S. Food and Drug Administration (FDA) posted additional information on its recently announced “Commissioner's National Priority Voucher” (CNPV) program, which will provide up to five vouchers in the program's...more
On July 10, 2025, citing a drive to increase transparency, the Food and Drug Administration (“FDA”) published more than 200 complete response letters (CRLs) previously issued to companies that had submitted new drug...more
Since our last update in April 2021, there have been many developments regarding biosimilars in Canada (approvals, pending submissions, litigation, regulatory and market access). Biosimilars approved in Canada - Health...more