My Green Doctor
MAY 3, 2025
That’s why our Practice Management program includes a guided, meeting-by-meeting path for helping clinics transition to renewable energy and cut utility bills—without overwhelming staff or adding to your to-do list. The product manufacturers and vendors will need to be active partners as well. Looking for a tailored approach?
FDA Law Blog
DECEMBER 16, 2024
The final guidance appears not to make any meaningful changes that are actually likely to support or incentivize its increased utilization, which is disappointing, although not unsurprising. The guidance also addresses FDAs obligation to provide considerations on third party compensation, information sharing, and conflicts of interest.
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FDA Law Blog
JUNE 16, 2023
Kirschenbaum — On May 24, Minnesota enacted the Commerce and Consumer Protection Omnibus Bill, Senate File 2744 ( SF 2744 ), which significantly expands the state’s existing drug pricing activities with serious implications for all drug manufacturers, and particularly generic drug manufacturers. We address each below. Best price?
FDA Law Blog
MARCH 20, 2022
Almost all recalls are conducted on a voluntary basis by the manufacturer. FDA has model recall communication templates available here that firms can utilize. Manufacturers hope for the best that their products are going to be used safely and effectively for patients and consumers.
FDA Law Blog
SEPTEMBER 20, 2021
First, CDER will publish a new MAPP (the Manual for Policies and Procedures, meant to guide CDER staff in their review activities and interactions with sponsors) describing: (1) early engagement with sponsors and (2) “science- and risk-based approaches” for CMC development that “may be warranted and utilized.
GeriPal
MAY 5, 2022
Association of Sensory and Cognitive Impairment With Healthcare Utilization and Cost in Older Adults. Including more hospital utilization or healthcare utilization, maybe cognitive impairment issues. My own work focuses on hospitalization and health utilization over time. Five big manufacturers. Is that right?
FDA Law Blog
AUGUST 21, 2023
Further, FDA has utilized a variety of strategies to call attention to safety issues through Dear Doctor letters or other forms of communication, even if directing changes to labeling is difficult. Liability is precisely why the vaccine market shrunk so significantly in the 1980s, going from 26 manufacturers to 4, after lawsuits claiming $3.5
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