May 30, 2023
The FDA is looking to revamp the information patients receive for prescription drugs and some outpatient blood products.
In a proposed rule announced today, the agency said it wanted to create a new Patient Medical Information guide that would help patients use their prescription drug products safely and address the rise of health care misinformation and disinformation.
The agency says the proposed drug labeling regulations strive to provide “clear, concise, accessible, and useful” information that helps patients better understand their prescription treatments.
“When such critical information is difficult to understand, patients can become frustrated, stop taking their medications, or not take their medications as directed, which can be harmful to their health,” FDA Commissioner Robert Califf, MD, said in a statement.
Here’s what you need to know:
“Having ready access to direct and easy to understand information in a consistent format for prescription drugs and certain biological products may reduce instances of both accidental and purposeful misinterpretations,” Califf said in the statement.
Additional information about the proposed rule is available online.
Tags: Public Health | Regulatory Advocacy
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