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All comments may be sent via email to using the comment form. The deadline for submission of comments is 30 May 2024.

For ease of reference, the key changes include the following:

1. Adoption of terminology harmonized with other FDA issuances being developed (specifically pharmaceutical product and active pharmaceutical ingredient).

2. Updated provisions under definition of terms, general conditions, and types of applications covering the identical pharmaceutical product applications (IPPA) to be established.

3. General provisions allowing bundling of applications for post-approval changes (specific conditions and requirements to be covered by implementing guidelines through FDA Circular).