Invitation: Open Scientific Discussion
Topic: Draft FDA Guidelines on "Replacing Color Additives in Approved or Marketed Drugs"
Date & Time: June 26, 2025 | 12:00 - 1:00 PM EDT
Dear AAPS/Excipient Community Members,
We invite you to join us for an important open scientific discussion regarding the recently released FDA draft guidance on color additives in pharmaceutical products. This session will replace our typical monthly presentation format to provide dedicated time for community input on this critical regulatory development.
Discussion Focus:
- Analysis of the draft guidance implications for excipient manufacturers and formulators
- Practical challenges and opportunities in color additive replacement
- Industry perspectives on implementation timelines and technical considerations
- Regulatory compliance strategies and best practices
Your Voice Matters: @Bruno Hancock and @Ketaki Patwardhan serve as the Excipient Community representatives on the AAPS Regulatory Response Committee. Your insights, concerns, and recommendations from this discussion will be directly channeled to the Regulatory Response Committee.
This is your opportunity to provide industry-wide regulatory feedback and ensure the excipient community's perspectives are heard.
Can't Attend? Please reach out to @Ketaki Patwardhan or @Bruno Hancock with your thoughts and comments.
Join us for this discussion!
AAPS Excipient Community Leadership
________________________________________________________________________________
Microsoft Teams Need help?
Join the meeting now
Meeting ID: 231 547 632 875
Passcode: o3Vy2hf6
------------------------------
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.
------------------------------