New draft guidance issued by the US Food and Drug Administration (FDA) is intended to clarify which changes to a pharmaceutical company's manufacturing process must be reported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

Regulatory approval is a major milestone in the drug development process, but by no means is it the final chapter in the journey. As drugs move out of trials and into market, researchers face many new ...

Every year, the global pharmaceutical industry produces trillions of doses of medications. Manufacturing these drugs involves several stages, and the chance of contamination increases with every step.

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. Dr. Reddy’s, an Indian generic ...