With PAT, pharmaceutical manufacturers achieve real-time process control, enhancing drug quality and accelerating the ...
The biotechnology company will use the federal pilot program for its planned $2 billion Saratoga Springs manufacturing campus ...
New draft guidance issued by the US Food and Drug Administration (FDA) is intended to clarify which changes to a pharmaceutical company's manufacturing process must be reported to federal regulators, ...
Amid an outpouring of industry investments in U.S. drug production, the FDA has launched a new program designed to significantly reduce the complexities involved in setting up domestic manufacturing ...
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