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

Reliance On ‘Digitized Paper’ Is Slowing Drug Development – US FDA’s Woodcock

Executive Summary

Efficient development and review is being hindered by the inability to exchange data freely and truly capitalize on the digital age, CDER director says, challenging industry, regulators and others to creatively think about how to move away from legacy, paper-based processes in clinical trials and regulatory submissions.

You may also be interested in...



Califf: More Learning Necessary During Generic Drug Lifecycle

The US FDA commissioner called for enhancements to postmarketing data collection and analysis for generic drugs.

US FDA’s Woodcock Sees Clinical Trial Reform Coming, But ‘Not Wholly Optimistic’

Acting FDA commissioner says there are a lot of strong forces in the research and pharma industries that could curb efforts to make pandemic-related clinical trial reforms permanent.

Califf Outlines Clinical Trial Reform Message, Which Could Travel With Him To Commissioner’s Office

US FDA commissioner-nominee Califf calls for streamlining clinical trial bureaucracy, as well as open access to clinical data.

Related Content

Topics

Related Companies

Latest News
See All
UsernamePublicRestriction

Register

PS124255

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