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

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

Executive Summary

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.

You may also be interested in...



Patient Preference Data: Pfizer’s Tanezumab Study Had ‘Flaws’ That Made It ‘Uninformative’

Study showed osteoarthritis patients are more willing to accept risk of joint damage with NGF-inhibitors than dependency associated with opioids, Pfizer said; however, FDA highlighted key flaws in study design, sample population and survey content.

PDUFA VII Negotiations Completed, Commitment Letter Ratification Ongoing

The US FDA, HHS and White House, as well as industry groups, now must sign off on the document.

Pandemic Perspectives: US FDA, NIH Tried To Be Flexible To Keep Rare Disease Trials Going

Both federal agencies extended grants to help investigators adapt to the changes mandated by the COVID-19 pandemic.

Related Content

Topics

UsernamePublicRestriction

Register

PS143895

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