June 2023 Question of the Month

How far in advance of NDA/BLA expected approval do (or should) manufacturers begin planning their compendia submission strategy?

During Phase II Trials: 0%

Initiation of Phase III Trials: 66%

6 months prior to approval: 33%

3 months prior to approval: 0%

At time of approval: 0%

After approval: 0%

No strategy: 0%