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(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,...
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(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)...
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(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...
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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...
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(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...
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(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...
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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...
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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...
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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...
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(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...