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

Curb Your Enthusiasm For Continued Use Of Pandemic Clinical Trial Flexibilities, US FDA Says

Executive Summary

Even though many approaches were successful, the agency may need a couple years to determine if the data generated were actionable.

You may also be interested in...



Cancer And Accelerated Approval: FDA To Crack Down On Single-Arm Trials, Refractory Disease Focus

US FDA cancer chief Rick Pazdur plans to send industry to ‘rehab’ with Project Frontrunner, which will push for development of cancer drugs in randomized controlled trials in earlier disease. Goal is to reduce time of uncertainty between accelerated approval and confirmatory evidence.

Could The US FDA Set Clinical Trial Diversity Minimums?

Oncology Center of Excellence Director Richard Pazdur asked whether the FDA should have more conversations with sponsors about site selection and percentages of US participants.

Clinical Trial Diversity: User Fee Bill Wants FDA’s Assessment Of Whether It Needs More Authority

HHS is to evaluate the need for FDA authority to mandate postapproval studies or postmarket surveillance if sponsors do not meet diversity enrollment goals. By contrast, the DEPICT Act would have given the agency the authority to do so.

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS146357

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