Medtech Insight 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 Targets Electronic Regulatory Submissions In Final Guidance

Executive Summary

The US agency’s new guidance doc lays bare the types of submissions device and drug makers should send to the agency electronically.

You may also be interested in...



New FDA Guidance Offers Additional Info On eStar Submissions

The US Food and Drug Administration says its guidance for manufacturers seeking premarket clearance is part of the agency’s overall commitment to improve e-submission consistency and enhance the review process.

New Guidance From FDA Lays Bare Types Of Submissions That Must Be Filed Electronically

A short, seven-page draft guidance from the US agency lists submissions that must be sent to the FDA in an electronic format.

Speaking Of Medtech, Ep. 10: FDA’s TAP Pilot

In this FINAL EPISODE of Speaking Of Medtech: The US FDA got something it desperately wanted in its latest user-fee package with industry: a Total Product Lifecycle Advisory Program pilot, or TAP. The agency says TAP will allow for earlier and more frequent engagement with developers – but is it needed?

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

MT142425

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