HEALTH AND SAFETY

» Drug, Devices, and Supplements

» Physician Accountability

» Consumer Product Safety

» Worker Safety

» Health Care Delivery

» Auto and Truck Safety

» Global Access to Medicines

» Infant Formula Marketing

 

More Information on the Design of Clinical Trials

Comments on FDA Draft Guidance on Postmarketing Studies and Clinical Trials

October 13, 2009

Docket No. FDA-2009-D-0283

Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852
Posted at: http://www.regulations.gov

Public Citizen has reviewed the draft guidance in detail and supports its purpose and approach. The guidance makes a sensible distinction between studies that are for efficacy purposes only (“postmarketing commitments”; these may be recommended but not required) and those that have any significant safety element (“postmarketing requirements”; these may be required). The categories of studies that can fall under postmarketing requirements (observational studies, clinical trials, animal studies, in vitro studies, pharmacokinetic studies, and interaction/bioavailability studies) are appropriately broad. We urge you to resist any efforts to weaken the draft guidance.

Peter Lurie, M.D., M.P.H.
Deputy Director

Sidney M. Wolfe, M.D.
Director
Health Research Group at Public Citizen

Copyright © 2016 Public Citizen. Some rights reserved. Non-commercial use of text and images in which Public Citizen holds the copyright is permitted, with attribution, under the terms and conditions of a Creative Commons License. This Web site is shared by Public Citizen Inc. and Public Citizen Foundation. Learn More about the distinction between these two components of Public Citizen.


Public Citizen, Inc. and Public Citizen Foundation

 

You can support the fight for greater government and corporate accountability through a donation to either Public Citizen, Inc., or Public Citizen Foundation, Inc.

Public Citizen lobbies Congress and federal agencies to advance Public Citizen’s mission of advancing government and corporate accountability. When you make a contribution to Public Citizen, you become a member of Public Citizen, showing your support and entitling you to benefits such as Public Citizen News. Contributions to Public Citizen are not tax-deductible.

Public Citizen Foundation focuses on research, public education, and litigation in support of our mission. By law, the Foundation can engage in only very limited lobbying. Contributions to Public Citizen Foundation are tax-deductible.