UNDATED – Due to high interest, the U.S. Food and Drug Administration (FDA) has reopened registration for a free virtual public workshop entitled “Roadmap to 2030 for New Drug Evaluation in Older Adults” on March 23, 2021.
This workshop will bring together stakeholders from academia, industry, and regulatory agencies in a virtual setting to discuss the current status of inclusion of older adults in clinical trials and strategies to ensure the safe and effective use of drugs in this population.
Americans are leading longer and healthier lives than ever before, but older adults often consume multiple prescription medications and maybe under-represented in pre-marketing drug evaluations, leading to insufficient data on the safety and effectiveness of medications for this population.
Initial pharmacokinetic/ pharmacodynamic studies and later clinical trials to evaluate age-related changes often do not include typical older adults who have multiple chronic conditions and take multiple medications. This can lead to insufficient data on the safety and effectiveness of medications in this population at the time of marketing approval.
Data on the safety and effectiveness of new medications likely to be prescribed in typical older adults, especially those at the oldest end of the age span, are critically needed. This workshop will discuss methods to ensure that the inclusion of older adults in drug evaluations is representative of the target population for treatment and will also discuss potential strategies to ensure safe and effective drug use in older adults.
Workshop Objectives:
- Review the current regulations and draft guidances for drug evaluation and labeling of medications for older adults
- Review the current data on the inclusion of older adults in clinical trials in selected key therapeutic areas
- Identify the gaps in regulations, guidances, and inclusion of older adults in data collection
- Explore approaches to close the existing gaps
The date, time, and location of the workshop are as follows:
Date: Tuesday, March 23, 2021
Time: 10:00 a.m. until 4:30 p.m. (EST)
Location: This is a virtual public workshop.
Meeting Information and Registration:
This workshop is open to the public and is free to attend, but registration is required. To register visit https://www.eventbrite.com/e/fda-roadmap-to-2030-for-new-drug-evaluation-in-older-adults-tickets-137460709683
If you have any additional questions about this workshop, contact OCPWorkshops@fda.hhs.gov.
