Manufacturing modern medicines is a multistage process, and each step introduces the opportunity for contamination, which can ...

Drug manufacturing process models represent a "growing area" of scientific development and have been utilized in new drug applications (NDAs), biologics license applications (BLAs), and supplements to ...

New draft guidance issued by the US Food and Drug Administration (FDA) is intended to clarify which changes to a pharmaceutical company's manufacturing process must be reported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

As microneedle drug delivery advances toward commercial manufacturing, packaging must protect delicate structures, support ...