Blog Entry

Draft Guidance on Geriatric Information in Product Labeling

The FDA recently released a draft guidance, which is now open for comments, intended to assist applicants of human prescription drug and biological products in determining the appropriate placement and content of geriatric information in labeling. Included in the guidance are recommendations for suitable information on the use of prescription drugs that is easy to understand and not confusing to geriatric patients, and that labels are consistently placed in proper so that the information is clear and accessible to health care practitioners and includes content that guides the safe and effective use in geriatric patients.

In general, for prescription drug labeling, the adult population is defined as patients 17 years of age and older, and the geriatric population is defined as patients 65 years of age and older. Therefore, information in labeling that is pertinent to the adult population is typically also pertinent to the geriatric population.

The following outlines the sections (requirements and recommendations) regarding placement of geriatric use  information in relevant sections of labeling when a drug is approved for a geriatric-specific indication that are included in this guidance:

  • Indications And Usage
  • Dosage And Administration
  • Warnings And Precautions
  • Adverse Reactions
  • Clinical Pharmacology
  • Clinical Studies
  • Omissions And Revisions

The draft guidance document replaces a withdrawn guidance, Content and Format for Geriatric Labeling (October 2001), and gives examples of geriatric use statements in labeling and examples of when FDA may permit applicants to omit or revise required information.

For more information and details download Geriatric Information in Human Prescription Drug and Biological Product Labeling

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