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

FDA Recommends HHS-Certified Electronic Health Records For Clinical Trials

This article was originally published in The Pink Sheet Daily

Executive Summary

Clinical trial sponsors are free to use any electronic health record system that meets FDA standards to collect clinical trial data, but the agency recommends use of Office of the National Coordinator for Health Information Technology-certified systems.

You may also be interested in...



Safety Events For Accelerated Approval Drugs Highlighted As Expansion Looms

US drugs with accelerated approval are more likely to experience a postmarket safety event, JAMA study finds; data sharing could be a solution to filling information gaps.

Massive Family Dollar Rat Infestation Leads To Multi-State Recall

The US FDA found more than 2,000 rats at an Arkansas Family Dollar distribution center, leadingto a six-state recall for products including feminine hygiene products, contact lens cleaners and face masks.

Digital Health Roundup: Exec Chats With Illumina, Bloom, AngelMed; M&A, Funding; FDA Down-Classifies Apps

In this roundup feature focusing on new developments in digital health, Medtech Insight spotlights IBM Watson Health’s divestiture and other financing news, Exec Chats with Illumina, AngelMed and Bloom, Philips’ new hand-held ultrasound device and autonomous robotic surgery, as well as the latest FDA news on digital health.

Topics

Latest News
See All
UsernamePublicRestriction

Register

PS079449

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