Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

Patient-Focused Drug Development: US FDA’s Guidance Development Effort Passes The Mid-Point

Executive Summary

Agency has issued two of four methodological draft guidances required under 21st Century Cures Act and convened workshops on the two documents still to come; industry, patient groups applaud FDA’s initiative but point to gaps in the guidance series, particularly around interactions with the agency on patient experience data and approaches to collecting patient preference information.

You may also be interested in...



US FDA's Patient Experience Data Guidance Calls More Attention To Burdens Of Surveys

Patient-focused drug development final guidance is little changed from 2019 draft but urges that quantitative data collection methods for issues important to patients need to easily usable by individuals with different abilities and cultural backgrounds.

Patient-Focused Drug Development, Complex Trial Design May Not Get More Funding In PDUFA VII

US FDA proposed increasing staffing and resources for both programs during the next user fee program cycle, but industry representatives did not believe it necessary.

Drug Costs Not A Primary Driver Of Rare Disease Economic Burden

EveryLife Foundation study finds inpatient and outpatient care, not prescription drugs, are the primary excess medical costs associated with rare diseases.

Related Content

Topics

Related Companies

Latest News
See All
UsernamePublicRestriction

Register

PS141504

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