FDA

Federal agency within the U.S. Department of Health and Human Services

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.

Tue, 01/22/2019 - 09:02
FDA Publishes User Guide for Participants in the Accredited Third-Party Certification Program Certification bodies can conduct food safety audits and issue certifications of foreign food facilities
Tue, 01/22/2019 - 09:02
(FDA: Silver Spring, MD) -- The U.S. Food and Drug Administration has published an Electronic User Guide for its Accredited Third-Party Certification Program Portal. In this voluntary program, established by the FDA Food Safety Modernization Act,…
FDA Provides $21.8 Million to States for FSMA Produce Safety Rule Implementation Awards help states implement multiyear produce-safety systems
Tue, 09/27/2016 - 15:04
(FDA: Washington, D.C.) -- The U.S. Food and Drug Administration (FDA) has awarded a total of $21.8 million to support 42 states to help implement the FDA Food Safety Modernization Act (FSMA) produce-safety rule. The rule, which the FDA finalized…
Piloting an Improved Intercenter Consult Process The future of medical product development?
Thu, 08/11/2016 - 13:06
(FDA: Washington, DC) -- During the last few months, we’ve shared what the FDA is doing to improve the review of combination products, including establishing the Combination Product Council and identifying necessary process improvements through…
Border Crossings Working with partners to verify the safety of imported produce
Thu, 04/07/2016 - 16:54
One of the vivid images that sticks with me from my tenure at the Food and Drug Administration (FDA) is of the port of entry at Nogales, Arizona. There, I saw large trucks from Mexico lined up as far as the eye could see, awaiting entry into the…
openFDA Makes Medical Device-Related Data Easier to Access and Use FDA believes you can use openFDA to create products that promote public health
Thu, 09/24/2015 - 12:05
(FDA: Silver Spring, MD) -- openFDA is releasing information on medical devices that could spur innovation and advance scientific research. openFDA’s application program interface expands on the previous openFDA resources concerning medical device…
New Guidance From FDA Helps Manufacturers Develop Biosimilars Four guidelines for industry offer useful tools for manufacturers
Thu, 05/28/2015 - 12:20
(FDA: Silver Spring, MD) -- The U.S. Food and Drug Administration (FDA) has taken important steps to help manufacturers develop biologic products called biosimilars. Biosimilars are highly similar to, and have no clinically meaningful differences…
What Kind of Fish Is That? DNA barcodes are improving the quality of the fish we eat
Tue, 04/29/2014 - 08:56
Have you sometimes wondered if that “wild caught” salmon actually came from an aqua farm? Or if the “U.S. catfish” in the display case might have been born and raised in Vietnam? Is that “red snapper” actually red snapper and worth the premium…
A New Era in Food Safety Oversight The FDA wields its FSMA authority against Sunland Inc.
Wed, 01/09/2013 - 09:39
Last December, Sunland Inc. entered into a court-ordered agreement imposing requirements that must be complied with if the company is to operate. This consent decree follows the Food and Drug Administration’s (FDA) suspension of Sunland’s food…
China Takes Steps to Strengthen Food Safety Improving food safety improves consumer confidence
Thu, 12/13/2012 - 14:51
An important message came through loud and clear during the Food and Drug Administration’s (FDA) whirlwind visit to China this month: China is determined to strengthen its food safety system. I had not visited China in nearly 10 years and I was…
FDA Inaugurates Annual Patient Network Meeting Office of Special Health Issues solicits patient input about medical products’ risks and benefits
Wed, 06/13/2012 - 11:54
(FDA: Washington, D.C.) -- The U.S. Food and Drug Administration (FDA) has a long history of working with patients and patient advocates, beginning with the AIDS crisis of the 1980s. Its interactions with patient groups have evolved since then, and…