“Being on-label and off-label really doesn’t mean much to people, as long as the medication is safe and effective without a dramatic risk for severe side effects,” says Dr. Steve Edelman, a well-known ...

Off-label prescribing is when a medication is prescribed for a purpose not approved by the FDA. Insurance might cover off-label prescriptions, but it depends on the specific plan and often requires a ...

When it comes to off-label promotion, FDA and industry have been engaged in a cat-and-mouse game for years. And in March, Congress got involved, too. The House Committee on Oversight and Government ...

The US Food and Drug Administration (FDA) issued a much-awaited draft guidance on October 24, revising its approach to the dissemination of scientific information on unapproved uses of ...

Off-label medication-drugs FDA-approved to treat one condition but often prescribed for another-are changing the game for ...

In March 2023, I started working at a large retail pharmacy as a technician. Bright-eyed and bushy-tailed, I donned my crisp, blue technician’s uniform complete with my slightly lopsided name tag on ...

The FDA updated its draft guidance on its handling of off-label communication for its regulated products, Gastroenterology and Endoscopy News reports. Here’s what you should know. 1. The update seeks ...

The US Food and Drug Administration (FDA) held a 2-day public hearing this week to solicit input about the marketing and use of medications and medical devices for off-label use. It is fairly common ...