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

Senate Bill Aimed At Streamlining Combo Product Regulation

This article was originally published in The Gray Sheet

Executive Summary

A Senate bill would streamline device/drug combination registrations at FDA by letting the agency rely on prior PMAs and approved drug findings to help support new product approvals, among other reforms. It was introduced by Sen. Johnny Isakson, R-Ga., and co-sponsored by Sens. Robert Casey, D-Pa., and Pat Roberts, R-Kansas.

You may also be interested in...



Combo Products Won't Get Special Review Pathway At US FDA Anytime Soon

FDA's Jeffrey Shuren and Janet Woodcock tell a Senate committee that the agency is more concerned with implementing combination product provisions from the 21st Century Cures Act than working on a novel review pathway for device/drug combination products.

21st Century Cures: Device Provisions

Dozens of reforms impacting the medtech sector were signed into law Dec. 13 as part of the 21st Century Cures Act. Here's a breakdown of the provisions most important to device- and diagnostic-makers.

21st Century Cures: Device Provisions

Dozens of reforms impacting the medtech sector were passed by the US House Nov. 30 in a compromise version of the 21st Century Cures Act that is expected to pass the Senate and be signed by President Obama before he leaves office. Here's a breakdown of the provisions most important to device- and diagnostic-makers.

Related Content

Topics

UsernamePublicRestriction

Register

MT034081

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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