Revise substance in 602

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Aug 6th, 2022

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How to revise substance in 602

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What type of changes in an approved product require a supplemental application?

(i) A supplement must be submitted for any change in the drug, production process, quality controls, equipment, or facilities that has a substantial potential to have an adverse effect on the identity, strength, quality, purity, or potency of the drug as these factors may relate to the safety or effectiveness of the

What is the FDA post approval process?

Post-approval studies are conditions of device approval. A sponsors failure to comply with any post-approval requirement may be grounds for the FDA to withdraw approval. (Note: A device may have more than one post-approval study imposed by a PMA or HDE approval order.)

What are post approval changes for drug products?

Variation/Post-Approval Change refers to a change to any aspect of a pharmaceutical product, including but not limited to change in the method and site of manufacture, specifications for the finished pharmaceutical product and ingredients, container, labeling and product information.

What are the current requirements of post-approval changes?

Recommendations are provided for postapproval changes in (1) components and composition, (2) manufacturing sites, (3) manufacturing process, (4) specifications, (5) container closure system, and (6) labeling, as well as (7) miscellaneous changes and (8) multiple related changes.

What is the new drug approval process?

There are three primary phases of the approval process: pre-clinical trials, clinical trials, and new drug application review.

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