FDA Law Blog
NOVEMBER 27, 2023
(the “Gree Companies”), an appliance manufacturer and two of its subsidiaries that were involved in the manufacturing, marketing, and sale of dehumidifiers. According to the government, these companies knew as early as 2012 that their dehumidifiers were defective, in that they could overheat and catch fire.
FDA Law Blog
OCTOBER 3, 2022
district court of Massachusetts by former employee and whistleblower Michael Bawduniak in April 2012 as a qui tam action. The government also suspects violative conduct if the speakers, attendees, or consultants are selected based on the volume of their past prescriptions of the company’s products or their expected future prescriptions.
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FDA Law Blog
MARCH 1, 2023
FDA published two Federal Register Notices in October 2020 to recruit domestic drug product manufacturers of finished dosage forms and foreign manufacturers of active pharmaceutical ingredients to participate in the QMM Pilot Programs. FDA describes the QMM as “above-the-bar behaviors” that exceed good manufacturing practices (GMPs).
FDA Law Blog
APRIL 8, 2024
For generic drug manufacturing facilities specifically, the numbers are 63% and 87%. The proposed Manufacturing Resiliency Assessment Program (MRAP) would be managed as a public-private partnership and would assign resilience scores to manufacturers of generic drugs, “based on an assessment of manufacturer practices and past performance.”
GeriPal
MARCH 2, 2023
And for that reason, there was actually an enormous lawsuit, and the manufacturer was fined, now I think 20 years ago, in the millions and millions of dollars for off-label prescribing. There was this big thing called the CMS National Partnership to Improve Dementia Care, started in 2012. But we should highlight that.
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