Final answer:
The specific number of days a sponsor has to report to the FDA after an IRB disagrees with a non-significant risk determination is not detailed in the provided information. However, sponsors are required to report serious adverse events within 15 days post-NDA approval.
Step-by-step explanation:
If an Institutional Review Board (IRB) disagrees with a sponsor's non-significant risk determination, the sponsor is required to report this disagreement to the Food and Drug Administration (FDA). However, the specific timeline for reporting such a disagreement is not mentioned in the provided texts. In general terms, sponsors have stringent timelines for reporting adverse drug events to the FDA.
For example, a sponsor must report unexpected serious and fatal adverse drug events within 15 days. Other events must be reported every quarter after New Drug Application (NDA) approval. Furthermore, the FDA's MedWatch program also allows consumers and health professionals to submit voluntary reports of adverse drug event reports. In cases where the FDA requires risk management plans or orders a clinical hold, additional monitoring and reporting may be mandated, which can include the sponsor's response to IRB disagreements over risk determinations.