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

US FDA's Abernethy 'Cautious' About Real-World Evidence

Executive Summary

FDA's principal deputy commissioner, who used to work in the real-world evidence field, said momentum is building, but more successful use cases are needed.

You may also be interested in...



US FDA’s Abernethy Leaves Behind Legacy Of Tech Modernization, Real-World Data

After slightly more than two years as second-in-command, Abernethy says she’s leaving FDA because her initiatives were starting to develop their own momentum. Abernethy, who the agency’s acting chief information officer, worked to modernize FDA’s information technology infrastructure and data capabilities while also exploring confidently using real-world data to support regulatory decision-making.

US FDA’s Amy Abernethy Leaves Behind Legacy Of Tech Modernization, Real-World Data

After slightly more than two years as second-in-command, Abernethy tells the Pink Sheet she’s leaving FDA because the initiatives on which she was focused were starting to develop their own momentum. Abernethy, who also serves as the agency’s acting chief information officer, worked to modernize the FDA’s information technology infrastructure and data capabilities while also exploring ways to confidently use real-world data to support regulatory decision-making.

US FDA Tech Modernization Plan’s Costs Uncertain

Agency officials determining needs using existing budgets before requesting more funds and will engage with tech investors for design advice.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS140596

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