Question: When making changes after the product is on the market, potential risk is used to determine whether FDA approval is needed. A CBE - 3
When making changes after the product is on the market, potential risk is used to determine whether FDA approval is needed. A CBE filing can be used for changes that are not high risk. Fillin the following blanks:
If after submitting a CBE to the FDA for changes to a product or process, a company has not heard any concerns from the FDA after A days, then the company is allowed toB
Question options:
A: days, B:Proceed with the changes, or put your product on the market with the changes, etc. Basically you are able to move forward without having to wait for FDA approval
A: days, B:Wait another days for the approval
A: days, B:Wait another days for the approval
A: days, B:Proceed with the changes, or put your product on the market with the changes, etc. Basically you are able to move forward without having to wait for FDA approval
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