Posted by Michael Wonder on 02 Jul 2019
Statement on steps to make health care professional and patient labelling information for prescription medications consistent and clear
1 July 2019 - The FDA is committed to making sure that health care professionals and patients have up-to-date, accurate and actionable information about prescription medications so that informed treatment decisions can be made.
We recognise that the choice of which medication to use, if any, for a particular patient is often a complex decision. These decisions involve a number of factors, such as assessing the progression of the disease or condition; looking at the other medications being taken; evaluating the ability of the patient to follow treatment regimens and instructions to help ensure safe use of a medication; and sometimes, assessing the risk of abuse and dependence of a medication for a particular patient.
As such, we continually work to help ensure that FDA-approved medication and biological product labelling (often referred to as the “package insert” or Prescribing Information) provides clear, complete information so that health care professionals have the essential information needed to make informed decisions and to facilitate safe and effective use of a medication.
