Pharmacy Owner Pleads Guilty

Posted on December 18th, by Gary Lerner in News, Pharmaceuticals.

Jose Carlos Morales co-owner of Pharmovisa, Inc. and PharmovisaMD Inc., pleaded guilty to to paying kickbacks and submitting fraudulent claims for pharmaceuticals to Medicare and Medicaid. According to the Department of Justice, Morales and his co-conspirators submitted false and fraudulent claims to the government agencies, which amounted to approximately $23,367,775.

FDA Seeks UDI Amendment Comments

Posted on December 17th, by Gary Lerner in Medical Devices, News, Regulations.

Last month FDA published an amendment to its July 10, 2012 UDI proposed rule (77 FR 40736). The amendment moves up the dates of compliance. Comments on this amendment to the proposed rule are due by December 19, 2012.

FDA Issues Proposed UDI Regulation

Posted on December 17th, by Gary Lerner in Medical Devices, News, Regulations.

“The unique identification system will enhance the flow of information about medical devices, especially adverse events and, as a result, will advance our ability to improve patient safety.” -FDA Commissioner Margaret A. Hamburg, M.D.

Qualitest Recalls 101 lots of Hydrocodone Bitartrate and Acetaminophen

Posted on December 10th, by Gary Lerner in News, Pharmaceuticals.

Bottles from the affected lots may contain tablets that have a higher dosage of acetaminophen, and as a result, it is possible that consumers could take more than the intended acetaminophen dose.

Unintentional administration of tablets with increased acetaminophen content could result in liver toxicity, especially in patients on other acetaminophen containing medications, patients with liver dysfunction, or people who consume more than 3 alcoholic beverages a day.

Industry News

Posted on December 5th, by Gary Lerner in Food & Beverage, Medical Devices, News, Pharmaceuticals, Regulations.