Category archives for: Canadian Drugs News

“Continuous Manufacturing” – Common Guiding Principles Can Help Ensure Progress

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By: Michael Kopcha, Ph.D., R.Ph. Today, a new and exciting technology – continuous manufacturing (CM) – can truly transform the drug manufacturing process so that it is more reliable and efficient. We discussed in a previous blog how CM enables a much faster and more reliable manufacturing process. In some cases, manufacturing that takes a month […]

Les Petits Mousses recalls three-drawer Vera storage unit

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Health Canada’s sampling and evaluation program has determined that the three-drawer Vera storage unit does not comply with the performance requirements of the ASTM F2057-14 International Standard Safety Specification for Chests, Door Chests, and Dressers. The product can tip-over if not securely anchored to the wall by using the tip-over restraints provided with the product, […]

Justice (Tween Brands Inc.) recalls various cosmetics

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Just Shine Shimmer Powder contains trace amounts of Asbestos. All other products from the same manufacturer are being recalled as a cautionary measure.

Smith Sport Optics, Inc. recalls Quantum Helmet

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The buckle on the helmet can become disengaged, posing a potential risk of head injury in a crash.

FDA’s plan to engage the public in the agency’s new effort to strengthen and modernize FDA’s regulatory framework

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By: Anna Abram We’re at a moment of extraordinary opportunity to improve the public health. New innovations are giving us fundamentally better ways to address disease. Some of the same technology is providing consumers with a broader selection of foods that can improve peoples’ diets, and products that can expand their choices. At the same […]

Tobacco Product Master Files: What Are They and How Could They Benefit You?

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By: Mitch Zeller, J.D. In a bid to help streamline and simplify the tobacco product application process and potentially reduce the associated costs, FDA is encouraging the creation and use of tobacco product master files (TPMFs). TPMFs are voluntary submissions to FDA that typically contain trade secrets and/or confidential commercial information about a tobacco product […]

Ameriwood Home of Tiffin, OH recalls Mainstays 4-Drawer Chest

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The recalled chest does not comply with the performance requirements of the ASTM F2057-14 International Standard Safety Specification for Chests, Door Chests, and Dressers. The product can tip-over if not securely anchored to the wall by using the tip-over restraints provided with the product, posing a tip-over and an entrapment hazard that can result in […]

Interoperability: FDA’s Final Guidance on Smart, Safe, Medical Device Interactions

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By: Bakul Patel, M.S., M.B.A. Imagine an intensive care unit for newborns. An interface on a device called a pulse oximeter is sending data on changes in the newborns’ blood oxygen level to a hospital computer system that simultaneously gathers data from EKGs that are monitoring the electrical activity of their hearts. By synchronizing time […]

A Look Back: The AIDS Crisis and FDA … 30 Years Later

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By: Richard M. Klein The first patient-focused office at FDA – and very possibly the first patient engagement office in the federal government – was the Office of AIDS and Special Health Issues, established in 1994 at the height of the AIDS epidemic. Richard M. Klein, a former entomologist in the agency’s New York Laboratory […]

BOMBARDIER RECREATIONAL PRODUCTS (BRP) recalls specific Evinrude E-TEC G2 150-300 HP Outboard Models

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The nuts on the gearcase and exhaust housing extension (if applicable) can loosen, allowing the gearcase assembly to detach from the outboard engine. In some circumstances, this may result in a sudden change in direction and loss of steering control, posing a risk of serious injuries or even death.

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