The safety profile of a therapeutic often changes over time, as more and more data is...

 

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The safety profile of a therapeutic often changes over time, as more and more data is collected and we come to better understand how a novel therapy acts in broader patient populations and over time. This change in the safety profile can hurt a product's Benefit: Risk relationship, such that if the safety profile starts to show signs of increased safety issues, this can increase the risk associated with the product and thereby offset the benefits disproportionately. Drastic safety-related changes in the Benefit: Risk profile of approved therapeutics can result in a hold being placed on their approval or even a complete removal from the market. One of how the FDA alerts the general public about approved therapeutics whose Risk profile has reached an unacceptable level is through Drug Safety Communications https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications Give one example of some form of safety-related change to a drug/biologic's status. The safety profile of a therapeutic often changes over time, as more and more data is collected and we come to better understand how a novel therapy acts in broader patient populations and over time. This change in the safety profile can hurt a product's Benefit: Risk relationship, such that if the safety profile starts to show signs of increased safety issues, this can increase the risk associated with the product and thereby offset the benefits disproportionately. Drastic safety-related changes in the Benefit: Risk profile of approved therapeutics can result in a hold being placed on their approval or even a complete removal from the market. One of how the FDA alerts the general public about approved therapeutics whose Risk profile has reached an unacceptable level is through Drug Safety Communications https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications Give one example of some form of safety-related change to a drug/biologic's status.

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