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By: FDA

(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, the agency recognizes “accreditation bodies” that may accredit third-party “certification bodies.” The certification bodies will be able to conduct food safety audits and issue certifications for food facilities, for both human and animal foods, and the foods they produce.

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The user guide is designed to help entities apply for recognition as accreditation bodies through the portal. The user guide will also help recognized accreditation bodies manage their accounts, including profiles of certification bodies they have accredited, in the portal.

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By: FDA

(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 in November 2015, establishes science-based minimum standards for the safe growing, harvesting, packing, and holding of fruits and vegetables grown for human consumption.

“As efforts for a nationally integrated food safety system advance, this funding will play a vital role in establishing programs at the state level to educate growers and provide technical assistance to ensure high rates of compliance with the produce safety rule,” says Melinda Plaisier, associate commissioner for regulatory affairs at the FDA.

In March 2016, the FDA announced the funding opportunity, which was available to all states and U.S. territories, to begin the planning for and development of a state produce safety program.

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By: FDA

(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 lean mapping of the combination product review process. We are pleased to update you on the proposed intercenter consult request (ICCR) process that will be piloted across the FDA today.

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By: FDA

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 United States‎, many loaded full with fresh produce.

I was told by our FDA team that, during the busy season, as many as 1,500 produce trucks enter the United States there daily, and Nogales isn’t even the busiest port of entry on the 2,000-mile U.S.-Mexico border.

That visit to Nogales happened during the early phase of the food safety modernization initiative at the FDA‎, but it had a lasting effect on me. It drove home the degree of difficulty we would face in fulfilling the produce safety vision embodied in the FDA Food Safety Modernization Act (FSMA).

With 50 percent of our fresh fruit and 20 percent of our vegetables coming from growers in other countries, the challenge was not only to establish produce safety rules that would be effective and workable across the hugely diverse produce sector, but also to verify with reasonable confidence that those standards are being met consistently, every day, regardless of where the produce is grown.

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By: FDA

(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-related adverse events and recalls by incorporating information from the medical device product life cycle. This includes current data on device classification (6,000 records), 24,000 registrations of device companies and establishments, and the companies’ listings of more than 100,000 devices.

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By: FDA

(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 from, an already approved biological product. Biosimilars can provide more treatment options for patients, and possibly lower treatment costs.

In early March, the FDA approved the first biosimilar, Zarxio (filgrastim-sndz), a biosimilar to Neupogen (filgrastim), which is used to help stimulate growth of white blood cells in patients with cancer and help them fight infection.

That’s a great start, and the FDA is pleased to see the progress. Manufacturers are working hard to develop more biosimilars for the U.S. market. By nature, biologic products are highly complex molecules, so developing biosimilar versions of these products is challenging. The FDA is also working hard to help those manufacturers bring more biosimilars to the market.

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By: FDA

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 price?

Scientists at the U.S. Food and Drug Administration (FDA) are able to answer those questions through a project that creates DNA barcodes to identify individual fish species. The massive project is part of an effort aimed at solving the problem of species substitution.

Species substitution can result in cheap fish being labeled as pricy ones, but mislabeling can also threaten public health. For example, in 2007, a prohibited and highly toxic variety of puffer fish, also known as fugu or blowfish, was smuggled into the United States in boxes labeled as “headless monkfish.” This deception resulted in illnesses in multiple states.

Jonathan Deeds Paddle Fish DNA Barcoding (350x230)

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By: FDA

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. The suspension came as a result of evidence linking Sunland to an outbreak of Salmonella Bredeney that sickened 42 people in 20 states, as well as the company’s history of violations. The company was barred from distributing food in intrastate or interstate commerce while its registration was suspended.

The consent decree may be seen by some as a final step in the process, but at the FDA we see it as a beginning. Certainly, it is a new beginning for Sunland, which must correct the problems identified during recent FDA inspections before being allowed to market its nut butter products. More broadly, though, it is the beginning of a new chapter in FDA history.

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By: FDA

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 struck by the extraordinary progress in the cities we visited. The towering skyscrapers, tree-lined boulevards, and the obvious signs of a rising middle class demonstrate the reality of an economy that has grown by leaps and bounds. That growth has led to rising consumer expectations, and China is clearly working hard to meet consumer and global expectations for safe food.

This message was repeated in meeting after meeting that Mike Taylor, Deputy Commissioner for Foods and Veterinary Medicine, and I had with Chinese officials. We saw a clear recognition of the scope and complexity of the challenge as well as a resolve—indeed, an enthusiasm—to take on the challenges head-on, and develop a modern, effective, and efficient food safety system.

Make no mistake: This will not be easy for China. It has considerable catching up to do in the science and daily practice of food safety, and in its legal system. But the enthusiasm and commitment we saw seems real and is backed up by action.

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By: FDA

(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.

The FDA’s Office of Special Health Issues (OSHI) is the agency’s primary interface with patients and the patient advocacy community. The OSHI educates patient advocates about medical product regulations and looks at ways to more effectively involve patients in regulatory decisions that affect them. It also assists patients with a broad range of patient issues related to approved and investigational medical products, including information about clinical trials and where to find studies, and about when access to investigational products outside of trials might be appropriate. The OSHI is expanding its efforts to communicate with patients by creating The Patient Network, a comprehensive new program designed to maximize its ability to reach out to patient groups.