A new guidance document issued by the US Food and Drug Administration's (FDA) drug and biologics review divisions explains how the agency handles Prior Approval Supplements (PAS) under its ...

President Trump wants pharmaceutical production to return to the United States. A shuttered factory in Louisiana shows how hard that will be for generic medicines. President Trump wants ...

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

New draft guidance issued by the US Food and Drug Administration (FDA) is intended to clarify which changes to a pharmaceutical company's manufacturing process must be reported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

Pharmaceutical manufacturing steps are often isolated in space and time. The synthesis, isolation and purification of the drug substance (DS) and the formulation of the drug product (DP) may be ...

Forbes contributors publish independent expert analyses and insights. The U.S. spent $722.5 billion on pharmaceuticals in 2023. Although brand-name drugs consume four out of every 5 dollars America ...

Scientists have developed a new strategy to enhance pharmaceutical production in Chinese hamster ovary (CHO) cells, which are commonly used to manufacture protein-based drugs for treating cancer, ...

While much of the conversation around the Trump administration’s potential pharmaceutical import tariffs has leaned heavily toward branded drugmakers, generic medicines and the companies that ...

A new analysis found that nearly 700 drugs approved for use in the United States depend on chemicals solely produced in China. By Rebecca Robbins See more of our coverage in your search ...

Patients filling prescriptions for a widely used generic cholesterol drug may find it missing from pharmacy shelves. The FDA ...