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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 slaughter facilities in January and February of this year from carcasses suspected with erysipelas.
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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 that up to 40% of all drugs Americans take are imported, and up to 80% of the APS in those drugs come from foreign sources. The Government Accountability Office says it would take FDA nine years to inspect all foreign facilities, according to the SOCMA statement.
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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 Drug Applications General Consideration
• Scientific Considerations in Demonstrating Biosimilarity To a Reference Product (draft already issued)
• Quality Considerations in Demonstrating Biosimilarity To a Reference Protein Product (draft already issued)
• Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009
(draft already issued)
In combination products:
• Development of Drugs in Combination
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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 and beverage companies automate energy and environmental monitoring while enabling real-time data collection.
This article provides an overview of wireless data node technology, discusses the benefits of real-time monitoring in production and warehousing facilities, and explains how food safety and facility management professionals can leverage the technology to lower monitoring costs, streamline recordkeeping for Hazard Analysis and Critical Control Points (HACCP) compliance, and help meet product quality objectives.
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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, and eligible phytosterol forms, and the FDA has even increased the required usage levels for phytosterols (0.5 g per RACC) in products bearing the claim. For years, all of this has been subject to an enforcement discretion period during which time manufactures have been allowed to go off of initial phytosterol requirements without penalty.
Most recently, the enforcement discretion period was set to expire on February 21, 2012. Products marketed after this date would have to meet all new changes to bear the heart health claim.
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