Final answer:
Side effects reported after a drug has been marketed are known as Postmarketing experience. This is a critical phase where drug safety and efficacy continue to be assessed based on real-world use, and any adverse events must be reported to the FDA.
Step-by-step explanation:
Side effects reported AFTER a drug has come to market are known as B) Postmarketing experience. This term refers to the monitoring of drugs after they have been approved by the Food and Drug Administration (FDA) and made available to the public. It's during this period that the postmarket safety surveillance occurs, where companies continue to monitor their drugs for long-term safety and in various subgroups of patients. Adverse drug experiences discovered post-approval must be reported to the FDA, often resulting from larger and more diverse patient populations using the drug compared to premarket testing.
It is essential that companies maintain a fair balance in their advertising, highlighting both the benefits and risks of their drugs, only promoting them for the indications approved by the FDA. Off-label refers to drug usage for indications not approved by the FDA, which is not part of the postmarketing experience.
Postmarketing experience is integral to the process of ensuring drug safety and efficacy, as it continues the assessment of the drug's performance in real-world conditions. This post-approval period can also include Phase IV trials or other risk management plans as required by the FDA.