In Vivo is part of the Business Intelligence Division 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
UsernamePublicRestriction

FDA Proposal Requires Firms To Submit Public Data On Pediatric Populations

This article was originally published in The Gray Sheet

Executive Summary

The Feb. 19 proposed rule implements requirements from the Pediatric Medical Device Safety and Improvement Act – passed as part of the 2007 FDA Amendments Act. The rulemaking was held up by concerns expressed by industry, which appear to have been addressed by the agency.

Advertisement

Related Content

FDA Withdraws Pediatric Data-Submission Rule, But Aims To Regroup Shortly
Rule On Pediatric Device Data Oversteps FDA Authority - AdvaMed
Device Pre-Market Submissions Will Soon Require Pediatric Information
Pediatric Device Developers Counting On Easier Path To Market

Topics

Advertisement
UsernamePublicRestriction

Register

MT032744

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