FDA plans system for standardized drug labeling

The General Services Administration has issued a request for information on behalf of the Food and Drug Administration about hardware and software for developing systems to process electronically drug label information.

Through the Structured Product Labeling Project, FDA wants to create a standard labeling system that will allow the exchange of information on all drug products marketed in the United States.

GSA's Federal Systems Integration and Management Center released http://www.fts.gsa.gov/fdaspl/docs/FDA_SPL_RFI.pdf the RFI.

The structured product labels would contain information such as how and when to use a product, dose recommendations and possible adverse effects. The goal is to improve patient safety by ensuring that the most up-to-date medication information is available to health care providers, patients and the public.

The project is part of the larger DailyMed Initiative, a partnership of FDA, the National Library of Medicine, medication manufacturers and distributors, and health care information suppliers.

The effort will require changes to regulations, development of standards, creating new IT systems, training, and changes in data entry and quality control of drug listings.

Responses to the RFI are due by Nov. 3. FDA wants to begin developing the system in February.

About the Author

Mary Mosquera is a reporter for Federal Computer Week.

Reader Comments

Please post your comments here. Comments are moderated, so they may not appear immediately after submitting. We will not post comments that we consider abusive or off-topic.

Please type the letters/numbers you see above

What is your e-mail address?

My e-mail address is:

Do you have a password?

Forgot your password? Click here
close

Trending

  • Dive into our Contract Award database

    In an exclusive for WT Insider members, we are collecting all of the contract awards we cover into a database that you can sort by contractor, agency, value and other parameters. You can also download it into a spreadsheet. Our databases track awards back to 2013. Read More

  • Navigating the trends and issues of 2016 Nick Wakeman

    In our latest WT Insider Report, we pull together our best advice, insights and reporting on the trends and issues that will shape the market in 2016 and beyond. Read More

contracts DB

Washington Technology Daily

Sign up for our newsletter.

I agree to this site's Privacy Policy.