2018 Healthcare Manufacturing Provider 
FDA Law Blog
JANUARY 18, 2022
In October 2014, FDA held a public workshop titled “Additive Manufacturing of Medical Devices: An Interactive Discussion on the Technical Considerations of 3D Printing.” The discussion paper provides an overview of FDA’s current approach to regulation of 3D-printed devices. use in education, construction, art, and jewelry).
FDA Law Blog
JANUARY 18, 2022
In October 2014, FDA held a public workshop titled “Additive Manufacturing of Medical Devices: An Interactive Discussion on the Technical Considerations of 3D Printing.” The discussion paper provides an overview of FDA’s current approach to regulation of 3D-printed devices. use in education, construction, art, and jewelry).
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The Medical Futurist
JUNE 21, 2025
Researchers say that the implant cannot provide any highly detailed vision – but it can help patients detect distinct patterns such as door frames and shapes. Their research showed promising results for lab rats, and they plan to carry out the first human trials in the second half of 2017 and gather preliminary results during 2018.
FDA Law Blog
NOVEMBER 20, 2024
Chemical characterization can also be useful in evaluating a change to the materials or manufacturing of a device. The draft guidance provides recommendations for collection and reporting of chemical characterization data and discusses the topics of information gathering, test article extraction, chemical analysis, and data reporting.
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
JUNE 15, 2022
Kirschenbaum — In 2017, the Centers for Medicare & Medicaid Services (“CMS”) issued a final rule to significantly decrease the rate the government will reimburse 340B hospitals in 2018 for outpatient prescription drugs from average sales price (“ASP”) plus 6% to ASP minus 22.5%. 52494 (Nov. Becerra, No. 20-1114, 596 U. S. _ (2022).
FDA Law Blog
FEBRUARY 28, 2022
The Agency’s goal is demonstrated in its definition of patient engagement: “Patient engagement is defined as intentional, meaningful interactions with patients that provide opportunities for mutual learning, and effective collaborations.” .
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