In Vivo 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

MDMA/FDA meeting

This article was originally published in The Gray Sheet

Executive Summary

Medical Device Manufacturers Association President Larry Holden and Director of Federal Affairs Mark Leahey plan to meet with FDA Acting Commissioner Lester Crawford and CDRH Director David Feigal June 4. Among probable discussion topics are a device user fee proposal negotiated by trade group AdvaMed and FDA. The proposal was recently excluded from bioterrorism legislation but could still be reconsidered by Congress this session along with Greenwood/Eshoo device reforms (1"The Gray Sheet" May 27, 2002, p. 3)...

You may also be interested in...



Kennedy To Industry: User Fees Still In Play If Third Party Sits This One Out

Industry supporters of medical device user fees are assuming a formidable challenge by linking the legislative proposal with the "Medical Device Amendments of 2001" (HR 3580), introduced by Reps. Jim Greenwood (R-Penn.) and Anna Eshoo (D-Calif.)

FDA Slacking In NDI Notification Enforcement; COVID-19 'Is Not An Excuse’ – NPA

In a statement submitted to the Senate Finance Committee, Natural Products Association CEO Dan Fabricant suggests two ways of improving compliance with new dietary ingredient notification requirements at negligible expense to the US FDA.

Finance Watch: Four IPOs In One Week, And Legend Is Year’s Largest So Far

Public Company Edition: Legend Biotech raised $424m in its US public market debut. Also, Pfizer commits up to $500m for equity investments and Allogene capitalizes on ASCO with a $550m offering.

UsernamePublicRestriction

Register

PL000723

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