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Slides

Including:

• Geriatric Patients in Clinical Studies
• Communicating Geriatric Information in Labeling

The goals of this webinar are to:

• Discuss FDA’s geriatric clinical data initiatives to increase the quantity and quality of information about the use of prescription drugs in geriatric patients (particularly clinical studies in patients for the treatment of cancer), and
• Help ensure that appropriate geriatric use information is consistently placed in prescription drug labeling so that the information is accessible to health care practitioners and guides the safe and effective use of prescription drugs in geriatric patients.

INTENDED AUDIENCE

This webinar is intended for industry, academia, and healthcare practitioners, including geriatricians, who:

• Design and conduct clinical studies (with a focus on clinical studies in patients with cancer)
• Develop, submit, review, or use prescription drug labeling

LEARNING OBJECTIVES

After this conference, participants will be able to:

• Discuss a history of FDA’s clinical study initiatives to increase enrollment of older adults
• Understand the importance of having adequate representation of older adults, including patients 75 years of age and older, in clinical studies for the treatment of cancer
• Incorporate geriatric use information into the Geriatric Use subsection and other subsections/sections of labeling (geriatric patients are defined as patients 65 years of age and older)
• Develop geriatric use information in labeling based on the sufficiency of the data to detect differences in safety and/or effectiveness between geriatric and younger adult patients
• Omit, revise, and/or update geriatric use information in labeling
• Understand available prescription drug labeling resources

TOPICS COVERED

This webinar will:

• Discuss the geriatric population in the United States
• Provide an overview of FDA’s initiatives to increase the enrollment of older adults (including patients 75 years of age and older) in clinical studies for the treatment of cancer.
• Discuss how to incorporate geriatric use information in the Geriatric Use subsection of labeling when a drug is approved for use in adult patients (including geriatric patients)
• Summarize geriatric use information in other sections and subsections in the labeling
• Discuss omitting, revising, and/or updating geriatric use information in labeling
• Provide prescription drug labeling resources

FDA SPEAKERS AND PANELISTS

Eric Brodsky, M.D.
Associate Director, Labeling Policy Team
Office of New Drug Policy, Office of New Drugs, CDER, FDA

Victor Crentsil, M.D.
Deputy Director (Acting)
Office of Immunology and Inflammation (OII) | OND | CDER | FDA

Harpreet Singh, M.D.
Director
Division of Oncology 2
Associate Director (Acting)
Cancer in Older Adults and Special Populations, OCE
OND | CDER | FDA

FDA RESOURCES

1. Draft guidance for industry, Geriatric Information in Human Prescription Drug and Biological Product Labeling (September 2020). When final this guidance will represent FDA’s current thinking on this topic.
2. Draft guidance for industry, Inclusion of Older Adults in Cancer Clinical Trials (March 2020). When final this guidance will represent FDA’s current thinking on this topic.
3. FDA’s Action Plan to Enhance the Collection and Availability of Demographic Subgroup Data.
4. Drug Trials Snapshots provides the public with information about demographic groups who participated in clinical trials that supported approval of new drugs.
5. Prescription Drug Labeling Resources.