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 Reorganization Advocates Seek Senate Boost For Disease-Oriented Structure

This article was originally published in The Gray Sheet

Executive Summary

Friends of Cancer Research proposes realignment of FDA to be organized more around disease areas and less around the distinctions between drugs, devices and biologics. The idea has generated some support from former commissioners and current officials, while others warn of unintended consequences.

You may also be interested in...



FDA's New Cross-Cutting Oncology Center Gets Pazdur As Lead

FDA's oncology drug guru Richard Pazdur will be heading a new cancer regulatory center aimed at bringing device, drug and biologics regulators together to support new innovations.

President Urges Breaking Down Of Drug, Device Distinctions, Regulatory Barriers

The White House held a summit on its Precision Medicine Initiative where President Obama emphasized the need to break down outmoded regulations, and suggested that the barriers between drug and device oversight need to be loosened. Also at the meeting: FDA and NIH announced new competitions and projects, including the launch of an effort to gather data from a million Americans over the next few years.

FDA Funding Proposal Includes Cross-Cutting Oncology Focus, Disappoints Budget Advocates

President Obama sent Congress a budget that would increase FDA's coffers by $360 million, but mostly from user fees. Advocacy groups say the proposal is insufficient considering the agency's growing responsibilities. Included in the request is money for a new Oncology Center of Excellence that would take a cross-agency effort to support development of combination therapies for cancer.

Related Content

Topics

UsernamePublicRestriction

Register

MT034410

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