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A New Era in Food Safety Oversight
By: FDA 01/09/2013

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 facility registration in November 2012.

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China Takes Steps to Strengthen Food Safety
By: FDA 12/13/2012

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.

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FDA Inaugurates Annual Patient Network Meeting
By: FDA 06/13/2012

(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 the agency now works with patients representing a broad spectrum of diseases and conditions.

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FDA Issues Draft Guidance on Biosimilar Product Development
By: FDA 02/13/2012

(FDA: Silver Spring, MD) -- The U.S. Food and Drug Administration (FDA) has issued three draft guidance documents on biosimilar product development to assist industry in developing such products in the United States.

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FDA and Industry Reach Agreement in Principle on Medical Device User Fees
By: FDA 02/06/2012

(FDA: Silver Spring, MD) -- The Food and Drug Administration (FDA) and representatives from the medical device industry have reached an agreement in principle on proposed recommendations for the third reauthorization of a medical device user fee program.

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Foreign Exporters Study U.S. Food Safety Law
By: FDA 10/03/2011

The Food and Drug Administration’s (FDA) international program has logged nearly 75,000 hits to its web pages on the new food safety law, as foreign companies that export food to the United States scramble to learn how the law affects them.

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Pilot Projects to Explore Ways to Trace Sources of Foodborne Illness
By: FDA 09/09/2011

(FDA: Silver Spring, MD) -- The U.S. Food and Drug Administration (FDA) has launched two new pilot projects to enhance the agency’s and industry’s ability to trace products responsible for foodborne illness outbreaks.

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The ‘Teeth’ of FDA’s Food Safety Law
By: FDA 08/16/2011

The Food Safety Modernization Act (FSMA), signed into law by President Obama in January 2011, has been called “historic” because it puts the focus of the Food and Drug Administration (FDA) on prevention—working to ensure that unsafe foods are not distributed in the first place.

FDA commissioner Margaret A.

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FDA Asks for Public Comment on Pathway to Lower-Risk Medical Devices
By: FDA 08/03/2011

(FDA: Silver Spring, MD) -- The FDA has announced that it will open a public docket to begin receiving public comments on the Institute of Medicine’s (IOM) report on the 510(k) program, the most common pathway to market for lower-risk medical devices.

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FDA Issues Draft Guidance on Premarket Notification for Medical Devices
By: FDA 08/01/2011

(FDA: Silver Spring, MD) -- The U.S. Food and Drug Administration (FDA) has issued draft guidance that clarifies when changes or modifications to a previously cleared 510(k) device require a new premarket submission.

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