Questions and Answers on Guidance for Industry: Medication Guides - Distribution Requirements and Inclusion in Risk Evaluation and Mitigation Strategies (REMS)
Q1. Why did FDA publish a draft guidance on Medication Guides?
A. FDA published a draft guidance on Medication Guides because the Agency has received comments from healthcare professionals and drug companies saying that they were confused about when they were supposed to distribute a Medication Guide in inpatient and outpatient settings where drugs are given to a healthcare professional for administration to a patient (e.g., in hospitals and dialysis centers). In these situations, the drug may be given daily or several times a week, and distributing a Medication Guide every time the drug is given may be difficult for healthcare professionals and not necessarily helpful for patients. FDA believes the draft guidance will help clarify when Medication Guides should be distributed and reduce some of the burden on the healthcare system.
Secondly, over the past several years, the Agency has, as a matter of policy, considered any new Medication Guide (or safety-related changes to an existing Medication Guide) to be part of a risk evaluation and mitigation strategy (REMS). The Agency has now determined that every Medication Guide will not necessarily be part of a REMS. Depending on the risks involved, the Agency will now approve some Medication Guides under only labeling regulations, and occasionally, also as part of a REMS.
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