Regulatory

The U.S. Food and Drug Administration has issued warning letters to three companies that manufacture and market mouth rinse products with claims that they remove plaque above the gum line or promote healthy gums. These claims suggest the products are effective in preventing gum disease when no such benefit has been demonstrated.

Warning letters were sent to, Johnson & Johnson with regard to its Listerine Total Care Anticavity Mouthwash brand; CVS Corporation for CVS Complete Care Anticavity Mouthwash; and Walgreen Company’s Walgreen Mouth Rinse Full Action .

Formerly DGP Group, Intelsius completes its corporate rebranding efforts, which includes a new corporate identity, logo, and redesign of its flagship Web site. As part of the rebranding, Intelsius also announced the launch of Orcatherm, one of its most innovative packaging solutions to date.

McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc., in consultation with FDA is voluntarily recalling all lots that have not yet expired of certain over-the-counter (OTC) Children’s and Infants’ liquid products manufactured in the United States and distributed in the United States, Canada, Dominican Republic, Dubai (UAE), Fiji, Guam, Guatemala, Jamaica, Puerto Rico, Panama, Trinidad & Tobago, and Kuwait. (See recalled product list below).

The recent passage of healthcare reform legislation is by no means the end of the debate over how to overhaul the U.S. healthcare system. Indeed, the real fireworks may just be beginning.

To help industry watchers and participants stay current with the reform bill’s enormous implications across multiple sectors, law firm Foley Hoag has launched a new blog with up-to-date postings on the legal, policy, and regulatory features of the changing healthcare and life sciences landscape.

FDA has approved a new formulation of the controlled-release drug OxyContin that has been designed to help discourage misuse and abuse of the medication.

A larger-size, RFID-enabled cabinet launched by Terso Solutions Inc. (Madison, WI) provides customized storage space to protect and track high-value inventories for healthcare suppliers and providers. The newly launched smart cabinet is well-suited for operating room supply centers and catheterization labs, as well as other environments where high-value items need to be controlled at the point of use.

A&M Biomedical (Laguna Hills, CA) has received ISO 13485:2003 certification from the National Standards Authority of Ireland Inc. A&M Biomedical offers medical device outsourcing services with an emphasis on quality and regulatory compliance.

Lisa Hawkins is the newest addition to the management team at Unicep Packaging Inc. (Sandpoint, Idaho). Ms. Hawkins now serves as the company’s director of quality. Ms. Hawkins joins Unicep Packaging from a former role at Celeste Contract Packaging L.L.C. (Easton, Md.). She brings more than four years of experience in all phases of medical device and pharmaceutical quality and regulatory affairs to the company.