Medtech Insight 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
UsernamePublicRestriction

Industry Calls on FDA To Relax Pediatric Device Requirements

This article was originally published in The Gray Sheet

Executive Summary

Device company representatives want FDA to make changes to the humanitarian device exemption process and provide other incentives to pediatric device developers.

You may also be interested in...



Asia Deal Watch: RAPT And Hanmi Partner On CCR4 Antagonist Offering Potential In Multiple Cancer Types

RAPT can earn up to $108m in milestones plus sales royalties under the deal. BerGenBio, Piramal partner on developing AML therapy.

Finance Watch: Omega, Perceptive/Xontogeny Raise $648m For Life Science Investments

Private Company Edition: Omega raised $438m for its sixth life science fund, while Perceptive and the accelerator Xontogeny partnered on a new $210m venture capital fund. In VC deals, Zentalis and Black Diamond raised $85m each.

Hanmi Says Sanofi Made 'Optimal' Efpeglenatide Decision, Still Eyes 2021 Approval

Hanmi Pharm is remaining upbeat after Sanofi’s decision to find another commercialization partner for efpeglenatide, saying it was the best strategy for the long-acting GLP-1 agonist given the strategic change in the big pharma’s diabetes strategy.

Topics

UsernamePublicRestriction

Register

MT033455

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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