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

Real-World Data: Sponsors Should Ensure US FDA Access To Patient-Level Data Upon Submission

Executive Summary

Informed consent from patients, or institutional review board waivers, are needed to allow bioresearch monitoring inspectors to review source records in a timely fashion without delaying a user fee date, FDA’s Cheryl Grandinetti tells an international good clinical practices workshop.

You may also be interested in...



Real-World Data: US FDA Sets High Bar For Electronic Health Records, Claims In Applications

Demonstrating that electronic health record and medical claims datasets are fit for purpose, and addressing potential limitations in advance, are key themes of new draft guidance.

US FDA Commissioner Califf Takes On Misinformation, Starting With ‘Rumor Control’

Agency leader expects to spend about a year developing a strategy to combat misinformation. On 5 August, the agency unveiled what appears to be an early component of the initiative – a web page titled Rumor Control, with facts about the safety and components of COVID-19 vaccines.

Monkeypox Vaccine: US FDA Eyes Dose-Sparing Strategy For Jynneos

Switching method of administration from subcutaneous to intradermal would increase by five-fold the number of doses of Bavarian Nordic’s vaccine available to combat the outbreak; an EUA declaration would be needed to make this change, FDA commissioner Robert Califf said.

Topics

Latest News
See All
UsernamePublicRestriction

Register

PS145815

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