What is the threshold for the FDA to require a REMS?
Explanation
The trigger for a REMS is not the type of drug or the number of side effects, but the severity of its potential harm. The FDA requires a REMS when a drug is associated with serious risks that require management beyond standard professional labeling.
Other questions
In what year did the Food and Drug Administration Amendments Act give the FDA the authority to subject drugs to new risk identification and communication strategies like REMS?
What does the acronym REMS stand for?
According to the text, what is the primary reason the FDA would require a REMS program for a drug?
What were the risk management programs acknowledged by the FDA in 2005 called?
What was a major limitation of the Risk Minimization Action Plans (RiskMAPS) that existed before the 2007 law?
Which of the following is NOT listed as a basic component of a REMS program?
Under what circumstances are 'Elements to Ensure Safe Use' (ETASU) required as part of a REMS?
Which of the following is explicitly listed as one of the 'Elements to Ensure Safe Use' in a REMS program?
At what two points in a drug's lifecycle can the FDA require a REMS?
What is required for a REMS associated with New Drug Applications or Biologics License Applications?
Which of these older risk management plans was used by the FDA before the creation of REMS?
If a REMS program requires that only specially certified pharmacies can dispense a particular drug, this falls under which category of REMS components?
The Food and Drug Administration Amendments Act of 2007 gave the FDA new authority to implement risk strategies during which specific period of a drug's lifecycle?
What is the scope of drugs for which a REMS can be required?
If a REMS requires a drug to be dispensed only in hospitals, what type of REMS component is this?
What does the text indicate about the trigger for the FDA requiring a REMS during the postmarketing period?
Which of the following describes the role of a 'Communication Plan' within a REMS program?
Which of the following scenarios would be an example of patient monitoring as an Element to Ensure Safe Use (ETASU)?
What was the identified flaw in the FDA's authority regarding RiskMAPS before the 2007 legislation?
All of the following are listed as 'Elements to Ensure Safe Use' (ETASU) EXCEPT:
Which statement best summarizes the evolution from RiskMAPS to REMS?
The text mentions that a REMS tag has been added to the monographs of drugs associated with these programs. What is the purpose of this tag?
A drug's REMS requires the prescriber to be certified and the patient to be enrolled in a registry. These requirements are examples of what?
What is the key difference between a Medication Guide and an Element to Ensure Safe Use (ETASU)?
In what year did the FDA acknowledge the pre-REMS programs as Risk Minimization Action Plans (RiskMAPS)?
Which entity is given the authority to require and enforce REMS?
What type of risk is a REMS program designed to mitigate?
Which of the following would NOT be considered a basic component of a REMS, but rather an 'Element to Ensure Safe Use'?
The authority for the FDA to create REMS came from what legislation?
If a patient must show documentation of a negative pregnancy test before a pharmacy can dispense a drug, this is an example of which REMS element?
What is the function of a patient registry as an Element to Ensure Safe Use (ETASU)?
Which of these is NOT one of the six specific 'Elements to Ensure Safe Use' (ETASU) listed in the text?
The development of REMS was necessary to address what specific issue with the older RiskMAPS?
When are 'Elements to Ensure Safe Use' (ETASU) deemed necessary for a drug?
A key component of REMS for new drug applications is a timetable for what activity?
Which of the following is NOT a risk management plan mentioned as being used by the FDA prior to 2005?
The central principle guiding the FDA's decision to require a REMS is to ensure that a drug's benefits outweigh its what?
If a drug manufacturer wants to ensure safe use, which element of a REMS would involve having specially trained healthcare providers prescribe the medication?
What is the primary function of a REMS tag in this specific drug guide?
How is a drug with an approved REMS program highlighted in the drug monographs described in the text?
When can the FDA require that pharmacies or practitioners be specifically trained or certified to dispense a drug?
What is the primary difference between how the FDA handled postmarketing commitments under RiskMAPS versus REMS?
Which of the following is NOT a purpose of a REMS program?
A drug's REMS requires patients to be enrolled in a registry. This requirement is considered what?
What does a timetable for submission of assessment, as part of a REMS, ensure?
The authority granted to the FDA in 2007 allows them to require new risk strategies for what?
According to the chapter, why might an 'Element to Ensure Safe Use' (ETASU) require a drug to be dispensed only in hospitals?
The core weakness of RiskMAPS was the inability to do what after a drug was approved?
The text lists six types of 'Elements to Ensure Safe Use' (ETASU). Which of the following is one of them?