Healthcare Individual Information Manufacturing 
Alabama Academy of Family Physicians
MAY 15, 2025
During the session, the Alabama Academy of Family Physicians actively represented the interests of its members on a range of healthcare initiatives. To incentivize donations to these hospitals, the bill suggests creating a tax credit for individuals and entities to offset their state income tax liability.
FDA Law
SEPTEMBER 19, 2023
Karst — Listing patent information in the Orange Book is a matter of judgment, but that judgment call is about to get a bit more scrutiny. The six-page statement explains that “Brand drug manufacturers may be harming generic competition through the improper listing of patents in the. Koblitz & Kurt R.
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FDA Law
NOVEMBER 29, 2023
Risk-based This guiding principle ensures risk management principles are used to evaluate the individual and cumulative changes over the life of the device. Transparency This guiding principle calls for manufacturers to be transparent with users regarding the device performance before and after the implementation of the change.
FDA Law
DECEMBER 12, 2022
How could the manufacturers even follow this guidance without illegally departing from their previously approved labeling? It looks similar to the type of procedural informed consent a surgeon ordinarily would present to a patient. After reviewing the information. What is going on here? Draft Guidance. Public Comments.
FDA Law
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
JANUARY 5, 2025
In response to the proposed rule, approximately 200 comments were submitted to the docket, and a meeting took place among FDA, the White House Office of Management and Budget (OMB) and the Consumer Healthcare Products Association (CHPA). Further elaboration of FDAs view would be helpful.
FDA Law
FEBRUARY 28, 2022
address common questions and misconceptions about collecting and submitting to FDA patient engagement information regarding the design and conduct of a medical device clinical study.”. The Guidance provides practical advice for device manufacturers to utilize patient engagement in clinical studies.
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