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Antibiotics[1] are drugs capable of killing bacteria or disrupting their reproduction without harming their host, and have been used for more than 70 years to treat people with infections and for more than 50 years in veterinary medicine. They have undoubtedly saved millions of lives, but the establishment of antibiotic-resistant bacteria is jeopardizing their effectiveness. [...]
The food industry is no stranger to risk management. In the battle for consumer dollars, product recalls caused by contamination or adulteration can be catastrophic. Business, legal and moral repercussions resulting from lapses in food safety and quality are top-of-mind issues for all manufacturers. Significant resources are dedicated to minimizing these risks, generally through a [...]
All pork producers – but especially those in the Midwest – are being urged to be on the alert for swine erysipelas. According to Pork Network.com, the American Association of Swine Veterinarians (AASV) reports increased incidences of the disease in finished and slaughtered hogs. And the USDA’s APHIS-Veterinary Services reports more condemnations at “multiple” Midwest [...]
The Bulk Pharmaceuticals Task Force (BPTF), an affiliate of the Society of Chemical Manufacturers and Affiliates (SOCMA), issued its support for the introduction of a House bill, the Generic Drug and Biosimilar User Fee Act (HR 3988), which SOCMA says will help to achieve parity between foreign and domestic firms. In its statement, SOCMA said [...]
FDA has issued a list of planned draft and final guidance documents for release throughout 2012. There are about 50 such guidances planned. Below are a few highlights for the drug-manufacturing space. In biopharmaceutics and biosimilarity: • Food-Effect Bioavailability and Fed Bioequivalence Studies— Bioavailability and Bioequivalence Studies for Orally Administered Drug Products Submitted in New [...]
Standalone data loggers have long been reliable workhorses for monitoring environmental conditions and energy efficiency in food and beverage manufacturing and storage facilities. However, collecting timely data from independent loggers distributed throughout large plant and warehouse facilities can present a number of challenges. Fortunately, a new generation of wireless data logging technology is helping food [...]
FDA says it will extend the enforcement discretion period for phytosterol-and-heart-disease claims until publication of a final rule. In September 2000, FDA issued an interim final rule allowing a claim of reduced risk of coronary heart disease (CHD) for eligible products fortified with phytosterols. Since then, parties have petitioned for more eligible products, eligible phytosterols, [...]
The Natural Products Association (NPA) has updated the popular Good Manufacturing Practices (GMP) training program, “What You Need to Know: How the FDA GMP Rule for Dietary Supplements Applies to You.” In light of the Food and Drug Administration’s emphasis on GMP inspections, this course is vital for anyone whose job requires an understanding of [...]
Dietary supplements are subject to a wide array of federal government regulations in the U.S., according to a new report published by the non-profit American Botanical Council (ABC), Austin, TX. The article notes numerous authorities to regulate dietary supplements that are granted to FDA and FTC, as well as other government agencies. The article, titled [...]
Orange-juice producers in Brazil, which supply about one in every six glasses drunk in the U.S., will stop using a fungicide that led shipments from the South American country to be detained, an industry group said. Carbendazim, a fungus killer banned in U.S. groves, will be removed from a list of chemicals approved by Brazil’s [...]
The U.S. Food and Drug Administration has released updated guidelines to help the seafood industry reduce or eliminate food safety hazards. This is the fourth edition of the “Fish and Fishery Products Hazards and Controls Guidance.” Revising the guidelines fulfills a mandate of the FDA Food Safety Modernization Act, which became law in January. The [...]
The FDA issued its updated draft guidance on new dietary ingredients (NDIs), which the agency said is intended to assist industry in deciding when a premarket safety notification for a dietary supplement containing a NDI is necessary. The guidance is also designed to help industry prepare NDI notifications. The draft guidance is laid-out in a [...]
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U.S. consumers are not only using supplements more than ever before, they are also more confident than ever in the safety, quality, and efficacy of supplements. These results were presented as part of the Council for Responsible Nutrition’s (CRN; Washington, DC) 2011 annual Consumer Survey on Dietary Supplements, made public at CRN’s annual conference in [...]
FDA says it will extend the enforcement discretion period for phytosterol-and-heart-disease claims until publication of a final rule. In September 2000, FDA issued an interim final rule allowing a claim of reduced risk of coronary heart disease (CHD) for eligible products fortified with phytosterols. Since then, parties have petitioned for more eligible products, eligible phytosterols, [...]
ADPEN brings aboard Agilent’s newest Triple Quadrupole LC-MS/MS, the 6490 with iFunnel technology. The 6490 has unprecedented sensitivity and is today’s most sensitive triple quadrupole mass spectrometer. It is designed to deliver high levels of sensitivity and robustness for even the most complex and demanding matrices. ADPEN has interfaced the 6490 with Agilent’s latest 1290 [...]