Has your healthcare provider ever talked to you about using an FDA-approved drug for an unapproved use (sometimes called an “off-label” use) to treat your disease or medical condition?

Jan 9, 2025 · Once an approved device or drug is available, doctors can prescribe it for any purpose they believe is warranted—regardless of what the label says. Indeed, sometimes it is …

May 14, 2025 · Off-label use refers to prescribing a medication for a different purpose than those formally approved by the FDA and found in the package labeling of the drug. The FDA …

Jan 7, 2025 · New guidance from the U.S. Food and Drug Administration walks back constraints the agency previously laid out on how drugmakers and other companies communicate with …

Jul 17, 2025 · The Food and Drug Administration’s (FDA) medication approval process is intended to ensure safe and efficacious use of medications in a studied population or disease …

Feb 23, 2021 · Prescribing for so-called off-label uses can be accepted medical practice, often reflecting cutting-edge clinical expertise. For example, this is the case with oncology drug use, …

Jun 5, 2025 · Off-label use is when you use a medication in a different way than what the Food and Drug Administration (FDA) approved it for. This includes taking a medication for a different …

Jul 9, 2025 · Off-label use means using an FDA-approved medication in a way that hasn’t been approved by the FDA. For example, a medication may be used for a different health condition …

Off-label prescribing is when a physician gives you a drug that the U.S. Food and Drug Administration (FDA) has approved to treat a condition different than your condition. This …

While the FDA highly regulates the premarket approval of all new drugs, it does not limit or control how medications are prescribed. Due to the rapidly changing, innovative healthcare …