The FDA is seeking feedback on the SUPAC guidelines that apply to formulation changes upon scale-up. Presumably members of this community might like to provide such feedback. For details see the recent post in the AAPS CMC Community for more details and please consider sharing your feedback in the coming weeks.
Chemistry, Manufacturing and Controls Community
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| Chemistry, Manufacturing and Controls Community |
| The FDA has announced the establishment of a docket [https://www.federalregister.gov/documents/2026/03/03/2026-04196/recommendations-on-scale-up-and-postapprova |
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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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