Featured Product
This Week in Quality Digest Live
FDA Compliance Features
Jill Roberts
Another way to know what’s too old to eat
Patricia Santos-Serrao
Four pharma quality trends
Del Williams
Preventing damage caused by large, suspended particles
Kari Miller
An effective strategy requires recruiting qualified personnel familiar with the process and technology

More Features

FDA Compliance News
Now is not the time to skip critical factory audits and supply chain assessments
Google Docs collaboration, more efficient management of quality deviations
Delivers time, cost, and efficiency savings while streamlining compliance activity
First trial module of learning tool focuses on ISO 9001 and is available now
Free education source for global medical device community
Good quality is adding an average of 11 percent to organizations’ revenue growth
Further enhances change management capabilities
Creates adaptive system for managing product development and post-market quality for devices with software elements
VQIP allows for expedited review and importation for approved applicants that demonstrate safe supply chains

More News

FDA

FDA Compliance

FDA Seeks Public Comments on Increasing Transparency With Regulated Industry

Electronic or written comments deadline is April 12.

Published: Monday, March 15, 2010 - 14:07

(FDA: Washington) -- As part of the final phase of its transparency initiative, the U.S. Food and Drug Administration (FDA) is seeking comment from the public and other interested stakeholders on how the agency can increase transparency in its interactions with regulated industry.

Posted in the March 12, Federal Register, the request for electronic or written comments has a deadline of April 12.

The FDA regulates products responsible for about 25 percent of the gross national product of the United States and the industries responsible for these products. Products regulated by the agency—biologics and blood products, human drugs, foods, medical devices, radiation-emitting devices, and veterinary medicines—are integral to public health and to the U.S. economy.

The agency formed an internal Transparency Task Force in response to the Obama Administration’s commitment to achieve “an unprecedented level of openness in government.” The Task Force is developing recommendations for making information about FDA activities and decisions more useful, understandable, and readily available, while appropriately protecting confidential information.

The Task Force held public meetings in June 2009 and November 2009. Based upon input received thus far, the Transparency Initiative has been divided into three phases. The first phase, creating a web-based resource called “FDA Basics” to provide information on commonly misunderstood aspects of the agency, has been completed. The second phase, improving FDA’s disclosure of information to the public, is underway and the agency intends to issue draft proposals for public comment soon.

The request for comment for the third phase follows a series of listening sessions with members of regulated industry in January 2010. Transcripts and summaries of those listening sessions are available at www.fda.gov/transparency and at www.regulations.gov.

For this final phase, the FDA is particularly interested in comments from all interested parties on how the agency can make improvements in the following areas:

  • Training and education for regulated industry about the FDA regulatory process in general and/or about specific new requirements
  • The guidance development process
  • Maintaining open channels of communication with industry routinely and during crises
  • Providing useful and timely answers to industry questions about specific regulatory issues

 

Electronic comments may be submitted to www.regulations.gov.

Submit written comments to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD, 20852. All comments should be identified with docket number FDA–2009–N–0247.

Discuss

About The Author

FDA’s picture

FDA

The U.S. Food and Drug Administration (FDA) is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable, and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.