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Dear Members VERY IMPORTANT ( The LAST DATE OF SUBMITTING COMMENTS IS JULY 13, 2026.) Please note FDA by a Notice on 03/03/2026 announcing the opening of a public docket to solicit information and comments on the Agency's series of guidances for industry on scale-up and postapproval changes (SUPAC) ...

Dear Members VERY IMPORTANT ( The LAST DATE OF SUBMITTING COMMENTS IS JULY 13, 2026.) Please note FDA by a Notice on 03/03/2026 announcing the opening of a public docket to solicit information and comments on the Agency's series of guidances for industry on scale-up and postapproval changes (SUPAC) ...

Please note FDA by a Notice on 03/03/2026 announcing the opening of a public docket to solicit information and comments on the Agency's series of guidances for industry on scale-up and postapproval changes (SUPAC) for specific dosage forms. To Submit either electronic or written comments on the notice ...

Hello all, For tomorrow's meeting on comments for SUPAC guidance on Manufacturing Equipment Addendum. Going through the addendum I did not find any information on actual scale-up for the pharmaceutical equipment for various processes. It has information on the operating principles only. Nothing about ...

I will be happy to volunteer for the CMC section, specifically for the Pharmaceutics of the product quality as I have education, knowledge and experiences in the past as a pharmaceutical scientist specializing in Pharmaceutics for the industry. Before the retirement from FDA I was the official mentor ...