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

US Senate bill aimed at streamlining combination product regulation

This article was originally published in Clinica

Executive Summary

A new US Senate bill, the Combination Product Regulatory Fairness Act of 2015, is intended to streamline device/drug combination registrations at the FDA by letting the agency rely on prior PMAs and approved drug findings to support new product approvals, among other reforms.

You may also be interested in...



FDA Commissioner Nominee Hahn Advances To Full Senate, Despite Some Dems’ Reservations

Stephen Hahn, the Trump administration’s nominee to lead the US FDA, has been approved by the Senate Health, Education, Labor and Pensions (HELP) Committee, with some “no votes” from Democratic senators in leadership positions, and is expected to be considered by the full Senate this week.

Congress Agrees To Keep FDA, Other Agencies Running At Current Funding Level Through Mid-December

The US Congress this week agreed to keep the FDA and other government agencies funded at fiscal-year 2019 levels, extending the continuing resolution another four weeks until 20 December.

Hahn Fields Queries On Electrical Stim Devices, Molybdenum Supplies For Imaging At FDA Confirmation Hearing

MD Anderson Cancer Center chief medical officer Stephen Hahn fielded a number of questions senators asked at his 20 November confirmation hearing to lead the US FDA. Chief among them were inquiries about his government experience level, whether he would expedite a ban on electrical stimulation devices used against the intellectually disabled, and how he would address a shortage of molybdenum-99 used in advanced imaging scans.

Topics

UsernamePublicRestriction

Register

MT102757

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