Featured Research

from universities, journals, and other organizations

Quantifying the FDA's rulemaking delays highlights need for transparency

Date:
February 3, 2014
Source:
Brigham and Women's Hospital
Summary:
Researchers quantify how long it takes the FDA to enact a formal rule affecting drugs, medical devices and other health-related products.

In a study published in Health Affairs on February 3, 2014, Aaron Kesselheim, MD, JD, MPH, and co-authors, quantify how long it takes the FDA to enact a formal rule affecting drugs, medical devices and other health-related products.

The FDA frequently uses rulemaking to establish or modify the way it regulates the medical product marketplace. Rulemaking may also be required by Congress or be needed to correct a public health problem. The FDA's rulemaking is controversial because of its perceived complexity, lack of transparency and lengthy duration. To shed light on the FDA's rulemaking process, the authors examined the evolution of the most important rules that the agency published during 2000-12.

The authors write, "We found that the rules' median time to finalization was 7.3 years, with the pre-rule phase and post review deliberation." Rules that involve cost-benefit analysis were associated with additional delays. The authors recommend, "The FDA's rulemaking could be improved by allocating additional resources to improve efficiency and by embarking on initiatives to promote transparency by the FDA and other parts of the executive branch."


Story Source:

The above story is based on materials provided by Brigham and Women's Hospital. Note: Materials may be edited for content and length.


Cite This Page:

Brigham and Women's Hospital. "Quantifying the FDA's rulemaking delays highlights need for transparency." ScienceDaily. ScienceDaily, 3 February 2014. <www.sciencedaily.com/releases/2014/02/140203171901.htm>.
Brigham and Women's Hospital. (2014, February 3). Quantifying the FDA's rulemaking delays highlights need for transparency. ScienceDaily. Retrieved October 1, 2014 from www.sciencedaily.com/releases/2014/02/140203171901.htm
Brigham and Women's Hospital. "Quantifying the FDA's rulemaking delays highlights need for transparency." ScienceDaily. www.sciencedaily.com/releases/2014/02/140203171901.htm (accessed October 1, 2014).

Share This



More Science & Society News

Wednesday, October 1, 2014

Featured Research

from universities, journals, and other organizations


Featured Videos

from AP, Reuters, AFP, and other news services

Japan Looks To Faster Future As Bullet Train Turns 50

Japan Looks To Faster Future As Bullet Train Turns 50

Newsy (Oct. 1, 2014) Japan's bullet train turns 50 Wednesday. Here's a look at how it's changed over half a century — and the changes it's inspired globally. Video provided by Newsy
Powered by NewsLook.com
US Police Put Body Cameras to the Test

US Police Put Body Cameras to the Test

AFP (Oct. 1, 2014) Police body cameras are gradually being rolled out across the US, with interest surging after the fatal police shooting in August of an unarmed black teenager. Duration: 02:18 Video provided by AFP
Powered by NewsLook.com
Ebola Cases Keep Coming for Monrovia's Island Hospital

Ebola Cases Keep Coming for Monrovia's Island Hospital

AFP (Oct. 1, 2014) A look inside Monrovia's Island Hospital, a key treatment centre in the fight against Ebola in Liberia's capital city. Duration: 00:34 Video provided by AFP
Powered by NewsLook.com
WH: We Can Stop Spread of Ebola in Its Tracks

WH: We Can Stop Spread of Ebola in Its Tracks

AP (Oct. 1, 2014) White House Press Secretary Josh Earnest reaffirmed the administration's confidence in the CDC's ability to keep the Ebola virus from spreading. (Oct. 1) Video provided by AP
Powered by NewsLook.com

Search ScienceDaily

Number of stories in archives: 140,361

Find with keyword(s):
Enter a keyword or phrase to search ScienceDaily for related topics and research stories.

Save/Print:
Share:

Breaking News:

Strange & Offbeat Stories


Science & Society

Business & Industry

Education & Learning

In Other News

... from NewsDaily.com

Science News

Health News

Environment News

Technology News



Save/Print:
Share:

Free Subscriptions


Get the latest science news with ScienceDaily's free email newsletters, updated daily and weekly. Or view hourly updated newsfeeds in your RSS reader:

Get Social & Mobile


Keep up to date with the latest news from ScienceDaily via social networks and mobile apps:

Have Feedback?


Tell us what you think of ScienceDaily -- we welcome both positive and negative comments. Have any problems using the site? Questions?
Mobile: iPhone Android Web
Follow: Facebook Twitter Google+
Subscribe: RSS Feeds Email Newsletters
Latest Headlines Health & Medicine Mind & Brain Space & Time Matter & Energy Computers & Math Plants & Animals Earth & Climate Fossils & Ruins