Appendix 2 comments sent to FDA from BFS IOA

BFS IOA board members had the pleasure to meet with Mr. Friedman and Mrs. Uratani of FDA in New Orleans and Prague, respectively. Technical Officers of the BFS IOA presented the associations comments to Appendix 2 in New Orleans and Prague PDA meetings. Mr. Friedman and Mrs. Uratani of FDA expressed, after the comment session on the concept paper, that the FDA is willing to listen to the arguments brought forward from the BFS industry via our organization. We are aware that the PQRI discussions are at or near conclusion, but we have forwarded our comment document for their reference and we hope they could consider them in the revision of the text. We trust and hope that the FDA and the BFS IOA can have continuing fruitful discussions and BFS IOA have expressed that we will more than happy to accept any invitation for further discussions on aseptic BFS processing with FDA.

To access and review BFS IOA's comment document, please click here.