Standard Response Letter

What is a Standard Response Letter?

A standard response letter is a pre-written and approved response that Medical Information teams have prepared for commonly asked or expected questions. For any given drug product, there will be a number of standard response letters compiled at the time of drug approval with more added over time as needs change. Letters often cover commonly asked questions about clinical data, but can also include information about pharmacokinetics, health economic data, and other relevant scientific data.