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How many days do you have to inform the TMB about supplying medical records?

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Final answer:

The sponsor must report serious and fatal adverse drug experiences to the FDA within 15 days of learning about them, with other events reported quarterly. The FDA's MedWatch program also collects voluntary reports.

Step-by-step explanation:

After the New Drug Application (NDA) approval by the Food and Drug Administration (FDA), the sponsor is obligated to monitor and report any adverse drug experiences to the FDA. Specifically, the sponsor must report unexpected serious and fatal adverse drug events within 15 days. For other adverse events that are not of this urgent nature, reports can be submitted on a quarterly basis.

The FDA also gathers information about adverse drug experiences through its MedWatch program. Health professionals and consumers can voluntarily contribute to this database by reporting any such experiences, which are then termed "spontaneous reports."

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