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

US FDA Expands Drug Development Tool Qualification Program With ISTAND Pilot

Executive Summary

ClinROs, artificial intelligence-based algorithms will be included in approval pathway. FDA is taking a crash course on new techniques for trial assessment thanks to COVID.

You may also be interested in...



US FDA Digital Health Center Will Help Prioritize Activities And Identify Needs

Significant resources will likely depend on the next user fee agreement, but the launch of a Digital Health Center of Excellence will help the US FDA better prioritize ongoing work in the emerging field and help to identify needs for new talent, Deputy Commissioner Abernethy says.

Drug Development Tool Qualification: US FDA Offers Three-Step Review Process

FDA's proposed review timeline to qualify biomarkers, clinical outcome assessments, and animal models can actually be pretty quick – assuming submissions clear the initial "reviewability" hurdle. 

CBER Staffing Remains Challenging, But Permanent Virtual Work May Help Offset Expected Retirements

Peter Marks predicts that staffing challenges within CBER can be alleviated by offering employees the flexibility to work remotely – permanently. With important posts in the vaccines office still to be hired, it could be an important incentive.

Topics

Latest News
UsernamePublicRestriction

Register

PS143401

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