Question

Form: contractual agreement between the sponsor and FDA.

Answer 1

The contractual agreement between the sponsor and FDA is a risk management plan or Phase IV trials, which involve additional clinical trials, studies, restrictions, or safety surveillance activities. Sponsors are also required to review and report all patient adverse drug experiences to the FDA.

Step-by-step explanation:

The contractual agreement between the sponsor and FDA in the context of drug approval and postmarketing surveillance is known as a risk management plan or Phase IV trials. These plans may involve additional clinical trials, studies, restrictions, or safety surveillance activities that sponsors are required to conduct as a condition of approval by the FDA.

The FDA also requires sponsors to review and report all patient adverse drug experiences, including serious and fatal events, to ensure postmarket safety. Sponsors must report these events to the FDA within specific timelines, such as 15 days for unexpected serious and fatal events, and on a quarterly basis for other events.

References:

1. Kevin Fain, Matthew Daubresse, G. Caleb Alexander (2013). 'The Food and Drug Administration Amendments Act and Postmarketing Commitments.' JAMA 310(2): 202-204.
2. 'Food and Drug Administration Amendments Act (FDAAA) of 2007'. Retrieved from www.fda.gov/oc/initiatives/advance/fdaaa.html
3. 'FDA Overview' (PDF). USFDA. Retrieved from www.fda.gov/downloads/training/ClinicalInvestigatorTrainingCourse/UCM283299.pdf
4. LibreTexts™