From my previous experiences I have learnt that its tricky to share recording due to IT policies of various companies. Good news is that we have captured detailed notes that we will share with everyone on the teams invite.
Ketaki Patwardhan Ph.D.
Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
Original Message:
Sent: 06-26-2025 11:10
From: Shahrzad Missaghi
Subject: For your feedback: Draft FDA Guidelines on "Replacing Color Additives in Approved or Marketed Drugs"
Thank you for setting up this meeting. It's such an important topic. Could it be recorded for those who cannot attend?
@Ketaki Patwardhan or @Bruno Hancock
Many thanks,
Shahrzad
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Shahrzad Missaghi
Senior Manager, Product Development
Colorcon
Harleysville PA
[email protected]
Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
Original Message:
Sent: 06-24-2025 15:38
From: Allison Radwick
Subject: For your feedback: Draft FDA Guidelines on "Replacing Color Additives in Approved or Marketed Drugs"
Hi Dave,
Apologies for the late response. For clarification, I had separate conversations with @Richard Creekmore, Kevin and @Catherine Sheehan where there may not be enough natural colors to replace the synthetic colors.
This month we will not have a monthly presentation. On June 26 from noon to 1pm EDT, we will use this time for members to share their thoughts on the recent guidance on color additives. @Ketaki Patwardhan and @Bruno Hancock will represent Excipient Community in the AAPS Regulatory Response Committee created for this guidance. We will channel collective community thoughts back to the Regulatory Response Team which then will be added to the formal response from AAPS.
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Join the meeting now
Meeting ID: 231 547 632 875
Passcode: o3Vy2hf6
AAPS Excipient Community Leadership Team
________________________________________________________________________________
Microsoft Teams Need help?
Join the meeting now
Meeting ID: 231 547 632 875
Passcode: o3Vy2hf6
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Allison Radwick Ph.D.
Sr Regulatory & Policy Comms Mgr
USP
East Fallowfield PA
[email protected]
Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
Original Message:
Sent: 06-09-2025 10:00
From: David Schoneker
Subject: For your feedback: Draft FDA Guidelines on "Replacing Color Additives in Approved or Marketed Drugs"
Hi Allison,
We can certainly invite Richard and Kevin if you would like. I'm not sure what you meant about "Excipients in the supply chain was also highlighted from this topic" as it relates to this new FDA guidance document about replacing color additives. Are you referring to the fact that there is not enough natural colors available in the world to replace the synthetic colors that are used or what are you referring to here?
Regards,
Dave
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David Schoneker
President/Owner/Consultant
Black Diamond Regulatory Consulting, LLC
Lansdale PA
[email protected]
Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
Original Message:
Sent: 06-06-2025 16:00
From: Allison Radwick
Subject: For your feedback: Draft FDA Guidelines on "Replacing Color Additives in Approved or Marketed Drugs"
We should invite Richard Creekmore and Kevin Hughes from IPEC Europe. We spoke about the guidance at the USP Convention meeting. The USP Excipients team would like to be a part of the conversation as well. We can schedule a meeting and see who responds and attends from the invite. Excipients in the supply chain was also highlighted from this topic.
I recommend that we set up a meeting specifically to discuss the color guidance this month. I don't think would be time for me to present on the color topic overall and still have time to discuss the guidance. Let's meet this month to talk about the guidance and then I can do a presentation next month as planned which will go significantly beyond this guidance.
Regards,
Dave
Sent from my mobile device.
Internal
IMPORTANT NOTICE: This email is from a legacy IFF.com email address associated with a former IFF business that was recently divested. The sender is no longer an employee of IFF or its affiliates and the use of this email by the sender is for a limited time and transitional purposes. The content of this email is not authorized by, or known to, IFF. The sender is now an employee of Roquette. Please use the sender's new email address at Roquette for any future communications.
Hi Ketaki,
I agree. Please use my new email address:
[email protected] in the future communications.
Best Regards,
Jin
Internal
Original Message:
Sent: 5/31/2025 12:28:00 PM
From: Bruno Hancock
Subject: For your feedback: Draft FDA Guidelines on "Replacing Color Additives in Approved or Marketed Drugs"
FDA released on Friday a draft guidance on "Replacing Color Additives in Approved or Marketed Drugs" for comment (attached). Comments are due to the FDA by 29Jul25.
AAPS will be providing comments on the guidance, and Ketaki Patwardhan and I will be compiling the feedback from the Excipients Community.
Please review the draft guidance and send your comments to [email protected] and [email protected] before the end of June so that they can be compiled with the feedback from the other AAPS Communities.
Thank you,
Bruno Hancock
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Bruno Hancock Ph.D., FAAPS
Partner
Aleurites LLC
Westerly RI
[email protected]
Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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