Ongoing FDA Dialogue

We wanted to update you on some exciting news from The 505(b)(2) Platform.  Our initial dialogue with FDA on behalf of The Platform has led to a positive working relationship with senior CDER officials.  They are happy to work with us on issues that are important to our membership, including ensuring that available guidance documents address the 505(b)(2) industry’s needs. 
 
To help FDA better understand these needs, the Agency has asked us to do two things.  First, they would like The 505(b)(2) Platform to identify the guidance documents that are relevant to this segment of the drug industry.  Second, they ask that we identify which documents are the most useful and which are inadequate or need updating.  Once we do so, we plan to request a meeting with FDA to discuss our members’ collective thoughts.  We hope that these discussions will then lead to the development of brand new guidance documents in areas where they are most needed.
 
While the FDA has The 505(b)(2) Platform and our recent discussions at the top of mind, please help us with the following:

• Which guidance documents are of primary importance to you and your organization?
• Which guidance documents need to be amended or expanded to reflect the current state of technology or science?
• Which topics would you like to see FDA address in new guidance documents?

Please send your thoughts via the contact form or comment below so that we may collate and curate responses.   

This initial effort to engage with FDA on guidance documents that are relevant to The 505(b)(2) Platform membership represents just the beginning of our Platform efforts.  We will need to prioritize other topics that are of concern to our members, and we welcome your feedback on topics that your organization would like addressed.