Answer :
The sponsor must submit an IND Safety Report to the FDA if an adverse event is
- serious
- unexpected
- there is a reasonable possibility that the drug caused the event.
What is Food and Drug Administration (FDA) ?
- Located under the Department of Health and Human Services, the Food and Drug Administration (FDA or USFDA) is a federal organization.
- The FDA is in charge of ensuring the safety of food, tobacco products, dietary supplements, prescription and over-the-counter medications, vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, animal foods & feed, and veterinary products in order to protect and advance public health.
- The Federal Food, Drug, and Cosmetic Act (FD&C) is the FDA's major area of enforcement, although the organization also upholds related regulations and other laws, most notably Section 361 of the Public Health Service Act. A large portion of this regulatory-enforcement job concerns the regulation of condoms, lasers, cell phones, and other items, as well as the prevention and control of disease in settings ranging from domestic pets to donated human sperm for assisted reproduction.
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