science

Risk Evaluation and Mitigation Strategies

Risk Evaluation and Mitigation Strategies is a science topic covered in the lgStudy science library. This page brings together a partial reference excerpt, illustrations, worked examples, real-world applications and a short study plan, so you can understand Risk Evaluation and Mitigation Strategies rather than just read about it. In short: Risk Evaluation and Mitigation Strategies (REMS) is a program of the US Food and Drug Administration for the monitoring of medications with a high potential for serious adverse effects. REMS applies only to specific prescription drugs, but can apply to brand-name or generic drugs.

Key takeaways

Risk Evaluation and Mitigation Strategies belongs to science; place it in that map before memorising details.
Learn the definition first, then one example that makes the definition concrete.
Connect Risk Evaluation and Mitigation Strategies to a quantity you can measure, compute or draw — that is where exam questions come from.
Reproduce the core statement of Risk Evaluation and Mitigation Strategies from memory before moving on to harder problems.

Reference excerpt

Risk Evaluation and Mitigation Strategies (REMS) is a program of the US Food and Drug Administration for the monitoring of medications with a high potential for serious adverse effects. REMS applies only to specific prescription drugs, but can apply to brand-name or generic drugs. The REMS program was formalized in 2007. The FDA determines as part of the drug approval process that a REMS is necessary, and the drug company develops and maintains the individual program. REMS applies only to specific prescription drugs, but can apply to brand-name or generic drugs. REMS for generic drugs may be created in collaboration with the manufacturer of the brand-name drug. The FDA may remove the REMS requirement if it is found to not improve patient safety. The REMS program developed out of previous systems dating back to the 1980s for monitoring the use of a small number of high-risk drugs such as isotretinoin, which causes serious birth defects; clozapine, which can cause agranulocytosis; and thalidomide, which is used to treat leprosy and certain cancers but causes serious birth defects. The 2007 Food and Drug Administration Amendments Act created section 505-1 of the Food, Drug, and Cosmetic Act, which allowed for the creation of the REMS program for applying individual monitoring restrictions to medications. Some of the provisions required by the REMS program are training and certification of physicians allowed to prescribe the drug, requiring that the drug be administered in a hospital setting, requiring pharmacies to verify the status of patients receiving REMS drugs, requiring lab testing of patients to ensure that health status is satisfactory, or requiring that patients be entered into a registry.

Usage As of 2025, there are 74 medications subject to REMS monitoring. 91% of these include "elements to assure safe use". These typically require clinicians or healthcare institutions to become certified prior to prescribing. 9% include only a "communication plan" REMS element, which is informational in nature. These communication plans are typically composed of letters, websites, and fact sheets describing the specific safety risks identified in the REMS.

Communication aspect In 2020, clinical settings enrolled in the REMS program asked the FDA to make their reviews of REMS compliance public so that they can more easily view the records and adjust to feedback. Between 2014 and 2017, the FDA stated they did not have enough data to determine whether the REMS program was sufficiently preventing opioid abuse. The Health and Human Services Office of the Inspector General recommended that parties in the REMS program provide the FDA more data. The FDA was habitually late in evaluating that data, reportedly leaving those parties with inadequate time to react to the review before their next assessment. In November 2020, the FDA planned to create a "Summary of the REMS Assessment" document that would publicize their assessments of clinical settings and manufacturers in the REMS program. The FDA made a public request for comment on the idea of publishing the Summary of the REMS Assessment. Without the publication of the summary, parties in the REMS program must request it using the Freedom of Information Act.

References

Worked examples

Example 1 — a first encounter with Risk Evaluation and Mitigation Strategies

Start with the simplest possible case. Write down what Risk Evaluation and Mitigation Strategies claims or describes in one sentence, then invent the smallest concrete situation in which that sentence is true. In science, the smallest case is usually a single object, a single equation or a single measurement. Check that every symbol or term in your sentence has a meaning in that case.

Example 2 — changing one variable

Take the situation from Example 1 and change exactly one quantity: double it, halve it, or set it to zero. Predict what should happen to Risk Evaluation and Mitigation Strategies before you calculate. Comparing your prediction with the result is the fastest way to find out whether you understand the idea or only the words.

Example 3 — an exam-style question

Typical questions about Risk Evaluation and Mitigation Strategies ask you to (a) state it precisely, (b) apply it to given data, and (c) explain a limitation. Practise writing all three answers in under five minutes; the third part is what separates a full-mark answer from an average one.

Applications of Risk Evaluation and Mitigation Strategies

In research: Risk Evaluation and Mitigation Strategies appears in science research whenever the underlying quantities have to be modelled precisely. Papers usually cite it as a starting assumption and then explore where it breaks down.
In technology and industry: Engineering practice reuses Risk Evaluation and Mitigation Strategies in design rules, simulations and safety margins. Knowing the idea lets you read a specification sheet and understand why the numbers look the way they do.
In the classroom: Risk Evaluation and Mitigation Strategies is common in secondary-school and first-year university syllabi. It links to neighbouring topics American organizations established in 2007, Drug safety, Food and Drug Administration, so understanding it makes those chapters shorter.
In everyday life: Look for Risk Evaluation and Mitigation Strategies outside the textbook — in sport, cooking, traffic, electronics or the sky above you. An example you found yourself is remembered far longer than one you were given.

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How to study Risk Evaluation and Mitigation Strategies in 20 minutes

Read the reference excerpt below once, without taking notes.
Close the page and write down what Risk Evaluation and Mitigation Strategies means in your own words.
Compare your version with the excerpt and mark what you missed.
Work through the three examples above with pen and paper.
Explain Risk Evaluation and Mitigation Strategies out loud to somebody else — or to Teacher Smith in the lgStudy chat.

Frequently asked questions

What is Risk Evaluation and Mitigation Strategies in simple terms?

Why does Risk Evaluation and Mitigation Strategies matter?

Because it connects several science ideas at once: it gives you a definition you can apply, a quantity you can calculate, and a way to check whether a result is plausible.

How should I study Risk Evaluation and Mitigation Strategies?

Read the excerpt, restate it from memory, then work through the examples and applications listed on this page. The five-step study plan above takes about twenty minutes.

What does this page cover?

It gives you a compact reference excerpt plus original lgStudy explanations, examples, applications and study material on Risk Evaluation and Mitigation Strategies.