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

Compliance Corner: Follow These 11 Steps To Prep For FDA Regulatory Meetings

Executive Summary

Longtime industry expert Steve Niedelman of the law firm King & Spalding offers manufacturers pointers so they’re not caught flatfooted during regulatory meetings with the US agency.

You may also be interested in...



Inspection-Challenged FDA Defies Odds By Issuing Most Quality-Related Warning Letters Since 2017

US FDA data shared with Medtech Insight show that the number of quality-related warning letters sent to device manufacturers in calendar year 2021 ticked up 33% from 2020. Last year’s enforcement missives were also the most handed out by the agency in four years.

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?

Thumbs Up: FDA Authorizes Weight Loss Suturing Systems From Apollo Endosurgery

People with obesity now have new tools to help them lose weight, thanks to the US agency’s de novo authorization.

Topics

Latest News
See All
UsernamePublicRestriction

Register

MT143828

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