Wednesday, 18 November 2020

Geriatric information in human prescription


 

New FDA draft guidance has been issued, titled ‘Geriatric information in human prescription drug and biological product labeling’

The draft guidance is intended to assist applicants of human prescription drug and biological products in determining the appropriate placement and content of geriatric information in labelling as described in the regulations for the content and format of labelling for human prescription drug and biological products.

The goal of this guidance is to provide recommendations to help ensure that appropriate information on the use of prescription drugs in geriatric patients is consistently placed in the proper sections and subsections within labelling 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.

See: https://www.fda.gov/media/142162/download 

 

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

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