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

FDA Seeks New Ways To Involve Patients In Regulatory Process

This article was originally published in The Pink Sheet Daily

Executive Summary

Industry hasn’t been shy about suggesting what changes it would like to see in FDA’s existing patient program, and opening of formal docket suggests agency is eager to rethink its approach.

You may also be interested in...



Patient-Focused Drug Development At 10: Where Does It Go From Here?

FDA may conduct more than the 20 required meetings by the end of fiscal year 2017, but how will the patient-focused drug development program find its place in helping generate new drugs?

“Patient Voice” Report Puts Chronic Fatigue Symptoms, Treatments In Benefit/Risk Framework

FDA report on CFS/myalgic encephalomyelitis is first of its kind from the patient-focused drug development initiative under PDUFA V. Incorporating comments from hundreds of patients and caregivers into a structured framework shows how the input may support a benefit/risk assessment for new products.

Woodcock Takes On Rare Disease Challenges In Retirement, Keeps FDA, Industry At Arm’s Length

Recently retired US FDA Principal Deputy Commissioner Janet Woodcock will be advising the Haystack Project, with the goal of helping rare disease organizations encourage creativity in drug development programs without jeopardizing regulatory success, Woodcock told the Pink Sheet in an interview.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS076692

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