EMA

March 28, 2019

Knock, Knock, Who’s There? Preparing for an FDA End of Phase II (EOP2) CMC Meeting

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 Odd Couple – Part 3: Authoring the Control of Excipients Modules

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.