As discussions intensify about how the second Trump administration will reshape the regulatory landscape for U.S.-based life sciences firms, less attention has been given to the new administration’s ...
The White House on May 5, 2025 issued an executive order requiring the US Food and Drug Administration to find ways to facilitate the opening of new drug manufacturing sites in the United States while ...
In a report published Monday, the Government Accountability Office (GAO) raises questions about the US Food and Drug Administration’s (FDA) foreign inspections program for drugs and says the program ...
John Clemons is a Solution Consultant for Rockwell Automation. He’s been working in the field of Manufacturing Technology for over 30 years. This year, we’re taking a close look at the use of ...
As a prerequisite and foundation for production and manufacturing, the design of product manufacturing process plays a crucial role in improving production efficiency, controlling resource consumption ...
Chimeric antigen receptor (CAR) -T-cell therapies have yielded remarkable results in the treatment of hematological malignancies. Several autologous CAR T-cell products have received marketing ...
Historically, pharmaceutical products have been produced in a traditional ‘batch’ system, in which every operation is executed separately using a defined quantity of materials. In batch manufacturing ...
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