Navigation Links
FDA Launches Website To Help Regulated Industries Save Time, Resources

SILVER SPRING, Md., Jan. 6, 2011 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today introduced a new Web resource called FDA Basics for Industry ( to help companies and others save time and resources in their interactions with the agency.


The website includes basic information about the regulatory process, including information that is frequently requested by industry.

"Clarity and consistency are pillars of an effective regulatory system that efficiently regulates products essential to health," said FDA Commissioner Margaret Hamburg, M.D. "In order to succeed, the FDA must clearly communicate standards and expectations to the industries it regulates."

Part of the agency's ongoing transparency initiative, the site is one of the 19 action items contained in a 46-page report titled "FDA Transparency Initiative: Improving Transparency to Regulated Industry." Other action items include:

  • setting an agency-wide expectation that e-mail questions to the FDA involving the regulatory process will, whenever possible, receive an answer within five business days, or a response stating when an answer can be expected
  • making agency presentations at key meetings widely available
  • developing and executing a project to promote uniform processes and procedures across field districts.

The entire list of action items contained in the report is available here.

"We have heard from small and large companies about the need for the FDA to more clearly communicate about its standards and expectations – both for regulated products generally and for specific applications," said Principal Deputy Commissioner Joshua Sharfstein, M.D., chairman of the agency's Transparency Task Force.

The report also contains five draft proposals to improve FDA's transparency to regulated industry. The draft proposals, available for public comment for 60 days, include publishing a timeline on the FDA website for high priority guidance documents in development. The FDA would disclose dates for publication of the draft guidance, receipt of public comments, and publication of the final guidance.

Commissioner Hamburg launched the FDA's Transparency Initiative in June 2009 in response to President Obama's commitment to openness in government and steps taken by the U.S. Department of Health and Human Services to make transparency a priority.

Since that time, the FDA has created a new Web page titled FDA Basics that features questions, answers, videos, and other materials describing how the FDA works to protect and promote public health. The page has been viewed by more than 900,000 people worldwide.

The agency also has established an online performance program for FDA offices nationwide. Called FDA-TRACK, the program features monthly metrics for more than 100 agency offices and provides insight for the public into the FDA's decision-making and regulatory activities.

For more information:

FDA Basics for Industry

FDA Transparency Initiative: Improving Transparency to Regulated Industry – Report

FDA Transparency Initiative: Improving Transparency to Regulated Industry – Executive Summary

Media Inquiries: Raymond Formanek Jr., 301-796-4677,

Other Inquiries: Afia Asamoah, 301-796-4625,

SOURCE U.S. Food and Drug Administration
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Iomai Launches Phase 1/2 Safety Study of Dose-Sparing Patch for Use With Pandemic Influenza Vaccine
2. Keeping the Data Center Clean: ATEN Launches Industry-First KVM Switches with Antimicrobial Nanocoating to Protect Products from Bacteria Surviving on Surfaces
3. Cell Therapeutics, Inc. (CTI) Launches Phase III Study for Pixantrone in Relapsed Indolent Non-Hodgkins Lymphoma (NHL)
4. Tengion Launches Second Phase 2 Clinical Trial of Regenerated Human Organ
5. Strategic Diagnostics Launches Initial Oncology-Targeted Antibody Reagent Catalog
6. deCODE Launches Phase II Clinical Testing of DG051 for the Prevention of Heart Attack
7. Premier Micronutrient Launches Supplement for Hearing Health
8. deCODE Launches deCODE MI(TM) -- A Test for a Major Genetic Risk Factor for Early-onset Heart Attack
9. PDHI Launches ConXus Rewards, Announces Partnership With Hallmark Insights to Support Incentive-Driven Wellness Programs
10. Seal Shield Launches Worlds First Antibacterial, Dishwasher Safe Keyboard and Mouse for Infection Control
11. Launches STD Social Networking Site Balancing Dating with Online Support Features
Post Your Comments:
(Date:11/24/2015)... 1, a free mobile-first network that enables healthcare professionals ... new completely redesigned web version that includes uploading. The ... primarily on a desktop, to upload images directly from ... base, Figure 1 is hosting an event during the ... (RSNA) Annual Meeting. Joshua Landy , ...
(Date:11/24/2015)... WATERLOO, Ontario , Nov. 24, 2015 ... in digital X-Ray image sensing technology, will introduce its ... 2015 Technical Exhibition , November 29 to December 3, at ... portfolio of dynamic detectors for diagnostic and interventional imaging will ... Xineos family of advanced CMOS X-Ray detectors ...
(Date:11/24/2015)... , Nov. 24, 2015  NuShield, Inc., an industry leader in LCD screen protection and glare-elimination ... computer technology as part of their patient monitoring or electronic documentation system. ... ... ... A study in ...
Breaking Medicine Technology:
(Date:11/24/2015)... ... ... Autism Speaks, the world’s leading autism science and advocacy organization, will take ... of people around the world. On December 1, supporters can make an online donation ... the personal stories behind those gifts. , Just as Black Friday and Cyber-Monday ...
(Date:11/24/2015)... Tennessee (PRWEB) , ... November 24, 2015 , ... ... Pharmacy Quality Trend Report . Throughout the past year there have been multiple breakthroughs ... mature state. During this transition, PharmMD has enabled their customers and partners to stay ...
(Date:11/24/2015)... ... ... am so thrilled, as a newbie here, to leave a mark for the entire staff,” ... Makeover® from California Casualty . Stephanie is in her fifth year teaching at Santan ... , “This is such an amazing school and we deserve a space where we can ...
(Date:11/24/2015)... ... November 24, 2015 , ... Add a fresh touch to ... easy and affordable way to bring long-lasting style and cheer to any space. , ... clean the air and keep on giving all year long. , “Holiday plants make ...
(Date:11/24/2015)... ... November 24, 2015 , ... Tudore Tranquility is a new restaurant in Tokyo, ... plant-based fine dining menu that is full of flavorful and creative dishes that exceed ... wedding dinner or a small intimate event. The décor looks stunning with gold and ...
Breaking Medicine News(10 mins):