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

FDA MDR COST ESTIMATES EXPECTED TO BE FOCUS OF REP. UPTON'S NEXT ROUND OF QUESTIONS ON MDR RULE; AGENCY STANDS BY $600 PER-ESTABLISHMENT FIGURE

This article was originally published in The Gray Sheet

Executive Summary

Rep. Fred Upton (R-Mich.) is expected to continue scrutinizing FDA's cost estimates for complying with the medical device reporting rule. Upton is drafting a letter to the agency that will express dissatisfaction with several responses FDA gave to a series of MDR-related questions posed by the legislator in May. One of the likely focal points of the upcoming letter will be the agency's defense of its cost estimates.

You may also be interested in...



ASH 2020: J&J/Legend’s Cilta-Cel Shines, But BMS/Bluebird’s Ide-Cel Is In First Place

Cilta-cel maintained high response rates in longer-term multiple myeloma data, but ide-cel causes less cytokine release syndrome and severe neurotoxicity – and it has a March decision date at the US FDA.

The Race To Develop A COVID-19 Vaccine: mRNA Pioneers Lead The Way

Our updated graphic tracker of key developments from the leading vaccine candidates.

LOXO-305 Comes Out Swinging In Battle Of BTK Inhibitors

Pathway open for drug as post-covalent BTK option as Loxo gears up for "risky" Phase III head-to-head study in Q1 2021.

UsernamePublicRestriction

Register

LL1135009

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