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(a) All data submitted below this section must be transmitted to FDA electronically in accordance with § 207.61(a) unless FDA has granted a request for waiver of the need just before the day on which submission of this kind of data is thanks. Submission of a request for waiver does not justification timely compliance With all the registration and

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As an example, if a specific inactive component continues to be authorised in a particular dosage type at a specific potency, a sponsor could take into account it safe to be used in a similar manner for the same form of product or service.In each situations the statutory prerequisite that should be satisfied is the same. Having said that, within th

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