Ellis F. Unger

Jan 15, 2025 | mondaq.com | Charles Raver |James Valentine |Ellis F. Unger |Frank J. Sasinowski

On December 5, 2024, FDA published a new draft guidance onaccelerated approval providing a much needed and substantial updateto its guidance on the pathway. FDA's application and use ofaccelerated approval has evolved dramatically since it was firstdeveloped by the Agency to help address the HIV/AIDS epidemic inthe late 1980s.

Jan 12, 2025 | thefdalawblog.com | James Valentine |Ellis F. Unger |Frank J. Sasinowski |Charles Raver

On December 5, 2024, FDA published a new draft guidance on accelerated approval providing a much needed and substantial update to its guidance on the pathway.  FDA’s application and use of accelerated approval has evolved dramatically since it was first developed by the Agency to help address the HIV/AIDS epidemic in the late 1980s.