The agency is asking for comments on a reflection paper on developing drugs for the needs of older patients.
On August 1, 2017, the European Medicines Agency (EMA) announced it was looking for public comment on a new reflection paper that takes a look at drug development specifically for senior adults. The paper asks developers to consider specific aspects of development to better suit the needs of older patients.
According to the agency, older adults may have special limitations, such as difficulty breaking a tablet by hand or having a hard time opening containers. EMA is asking drug developers to consider routes of administration, dosage forms, dosing frequency, excipients, container closure systems, devices, and user instructions that may need to be tailored to an older population. The agency is especially looking for comments regarding tablet breaking, feeding tubes, and compliance aids.
Public comment is open until Jan. 31, 2018.
Source: EMA
Drug Shortages and Complying with FDA’s 21 CFR 211.110 Guidance
April 2nd 2025Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Rona LeBlanc-Rivera, PhD, principal consultant, Regulatory Affairs at Regulatory Compliance Associates, answer some questions about FDA’s January 2025 21 CFR 211.110 guidance document.
AES Clean Technology Launches Next-Generation OSM Utility Solution for Cleanrooms at INTERPHEX 2025
April 2nd 2025Officially launched at INTERPHEX 2025, the Omni ASCENT is a next-generation off-site manufactured vertical utility solution that offers optimized cleanroom flexibility and efficiency.