Geriatric Information in Human Prescription Drug and Biological Product Labeling Guidance for Industry

On 15 September 2020 the FDA announced the availability of the draft guidance for industry. Comments may submit by 16 November 2020.

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

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