Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

REMS Assessment Paradigm To Be RE-AIMed By FDA; “Pressure-Testing” Needed

Executive Summary

The agency plans to use the RE-AIM model, which looks at an intervention’s reach, effectiveness, adoption, implementation and maintenance, as the basis for guidance on evaluating whether a REMS protects patient safety without being unnecessarily restrictive and burdensome on patient access.

You may also be interested in...



Whose Burden Is It Anyway? REMS’ Health Care Impact Belongs To FDA, PhRMA Says

Industry group contends that FDA should assess whether a REMS places an undue burden on the health care industry – because asking companies to do that evaluation would be an additional burden on the health care system.

FDA Plans To Improve REMS Effectiveness With Guidance On Goals And Metrics

The agency cited the forthcoming guidance in response to an HHS Inspector General report that questions the effectiveness of the risk management program.

REMS Assessments Could Measure Behavior, Not Just Knowledge, Industry Tells FDA

Lilly suggests a hierarchy of metrics at an agency workshop: At the lower end, surveys could elicit respondents’ knowledge about a drug’s risk, but also seek information about their behavior and the impact of the REMS on access to the medication; for riskier drugs, secondary data could be utilized to assess behavior; for the riskiest drugs, the effect of behavior on outcomes could be assessed.

Topics

UsernamePublicRestriction

Register

PS055542

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel