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

MDUFMA Addresses In Vitro Diagnostics, Combination Product Regulation

This article was originally published in The Gray Sheet

Executive Summary

FDA will be required to report to Congress on Center for Biologics Evaluation & Research review times for in vitro diagnostics under the "Medical Device User Fee and Modernization Act" of 2002 (MDUFMA), which cleared the House Energy & Commerce Committee Oct. 2

You may also be interested in...



Combination Product Submissions Rose 10% In FY 2005 – FDA

FDA received 275 applications for combination products in fiscal year 2005, a 10% increase over the prior year, according to a May 29 report to Congress

Combination Product Submissions Rose 10% In FY 2005 – FDA

FDA received 275 applications for combination products in fiscal year 2005, a 10% increase over the prior year, according to a May 29 report to Congress

CBER Review “Paradigm Shift” Credited With Improved Cycle/Review Stats

The Center for Biologics Evaluation & Research is working to identify problems with premarket applications earlier so they can be resolved in the first cycle of review, according to Robert Yetter, CBER associate director for review management

Related Content

UsernamePublicRestriction

Register

SC143384

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