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Hello,
I have some questions regarding post approval changes to ANDA applications.
1) If we intend to relax an acceptance criteria for an excipient specification (Example: Relaxing PSD for excipient) would this be considered a PAS or can this be submitted as a CBE-30 with data showing that this will not affect the product? Please note that this is not a compendial change and this excipient will be used in manufacture of finished product.
2) If FDA updates their dissolution database for a particular product (For example: Apparatus II to Apparatus III) would we be expected to submit a PAS or can this still be submitted as a CBE-30 with supporting data since we are implementing the updated dissolution method.
Would it be wise to submit both the above changes in the same supplement?
Thank you.