Pink Sheet 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 Drug Safety Office Would Have $100 Mil. Budget Under Dodd Bill

This article was originally published in The Pink Sheet Daily

Executive Summary

The senator plans to introduce legislation that would establish a new FDA safety office dubbed the Office of Patient Protection. The OPP director would report to the FDA commissioner, and would have the authority to withdraw a drug from the market if it poses a safety risk.

You may also be interested in...



Drug Safety Legislation Unlikely, BIO CEO Greenwood Says

Trade association's new chief sees no "great case for, or inclination on the part of the Senate leadership...to legislate on this topic." Upcoming Health Committee hearings may persuade senators to withdraw proposed legislation on drug safety issues, Greenwood says.

Drug Safety Legislation Unlikely, BIO CEO Greenwood Says

Trade association's new chief sees no "great case for, or inclination on the part of the Senate leadership...to legislate on this topic." Upcoming Health Committee hearings may persuade senators to withdraw proposed legislation on drug safety issues, Greenwood says.

FDA Drug Safety Reform Must Come From Outside Agency – Sen. Grassley

Oversight of the agency's drug safety functions is "going to have to be outside the FDA," Senate Finance Committee Chairman Grassley tells HHS Secretary Leavitt. Grassley still wants drug safety reviewers to have guaranteed independence from the Office of New Drugs, despite plans for a new Drug Safety Oversight Board.

Related Content

Topics

UsernamePublicRestriction

Register

LL1134882

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