March 28, 2019
Three rules of engagement are recommended to take place at an End of Phase II meeting, either face to face or by telephone. Each rule helps to ensure a successful negotiating strategy based on the actual discussions with the Agency.
July 2, 2020
The acceptance criteria and tests conducted for the excipients should be reviewed relative to the preformulation experimental results. The acceptance criteria for the excipients should consider those qualities critical to the drug product performance and manufacturing operation as described earlier in formulation development.