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Briarcliff767, FDA-expert
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Experience:  Research and Records
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We have an older product with a well-established safety

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We have an older product with a well-established safety profile (no risk management plan in place in the U.S.) for which we are about to submit a supplement for a new indication. The Agency has agreed to consider the submission and approval based on data derived from already conducted studies (by us) in addition to data from studies performed by others with our product. Are we required to submit a Risk Management Plan as part of the sNDA and / or commit to continued monitoring. Thank you
Submitted: 3 months ago.
Category: FDA
Expert:  Briarcliff767 replied 3 months ago.

HI, My name is ***** ***** I am happy to assist you. Yes any changes to a product no matter how old or new the product is will need to have the Risk Management Plan conducted and the FDA will need to be notified of any changes to the other product. You can add that to your already approved product. Please let me know if you have further questions.

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