With PAT, pharmaceutical manufacturers achieve real-time process control, enhancing drug quality and accelerating the ...

The U.S. Food and Drug Administration today issued a proposed rule that, if finalized, would create a streamlined ...

New draft guidance issued by the US Food and Drug Administration (FDA) is intended to clarify which changes to a pharmaceutical company's manufacturing process must be reported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, ...

Designing an efficient platform is crucial for any industrial process. This design process is known as process development, and it has become increasingly important in the pharmaceutical industry at ...

USP standards enhance reliability by reducing process variability, improving technology transfer, and supporting regulatory alignment, particularly relevant for generics and multi-site manufacturing ...

From the moment we could look up to the skies, humanity has dreamt of what’s up there. And once we got there, how could we master it? And now that we’re there all the time, how can we use it? In 2025, ...

July 10 (Reuters) - The U.S. FDA on Friday proposed a rule to streamline registration requirements for certain drug ...

A single type of chemical structure that shows up again and again in modern medicine is the amide bond that links a carbonyl group (C=O) to a nitrogen atom. They're so ubiquitous that 117 of the top ...

Pharmacy benefit managers received substantial attention during 2024. Congress and regulating agencies including the FTC and HHS scrutinized PBM business practices and related profits. As a new ...

Demand for GLP-1 drugs such as semaglutide is exposing capacity gaps across peptide APIs, sterile fill-finish facilities, injector devices and glass cartridges ...