Companies will sometimes receive a written communication from FDA regarding either a pending product submission (e.g. a request for additional information), a compliance related matter (e.g. a 483 or a Warning Letter), or some other type of general communication (e.g. a letter to the industry regarding a policy change). It is important for companies to know how to go about responding to such communications in a way as to provide them with the best opportunity for successfully dealing with the issue at hand. 6 Join the Conversation ACI: Pharmaceutical/Biotech/Life Sciences @ACI_Pharma / #ACIFDA There is no one set of answers for every response. Often times the specifics of the response depend upon the type and substance of the communication, who in FDA sent it, the circumstances surrounding the issuance of the communication, as well as the regulatory history of the company. This presentation will provide valuable insights, gained from years of experience, and will cover the following topics:

• Who at FDA is the response to be addressed to?
• Who should the response be written for?
• How do you assure that you have addressed all of the issues FDA is concerned with (and it’s not always the issues that are articulated in the FDA communication)?
• At what level of complexity/specificity should the response be written?
• Who should be the signatory of the response?
• What if any follow-up should the company engage in?