An FDA draft guidance nixing the requirement for biosimilar manufacturers to conduct comparative efficacy studies may prove ...

The Food and Drug Administration (FDA) development and approval process for drugs and medical devices involves multiple phases that ensure the safety and effectiveness of products before and after ...

The U.S. Food and Drug Administration has delayed reviews of two drugs chosen for the Trump administration's new fast-track ...

A new study co-written by a University of Illinois Urbana-Champaign expert in operations management finds that drugs approved ...

FDA approval describes when the Food and Drug Administration (FDA) deems a medical product safe and effective for its intended use based on scientific data and testing. Before people use a medical ...

FDA staffers and outside experts worry the program runs afoul of legal, ethical and scientific standards used to review new ...

A senior Food and Drug Administration official on Friday said the agency will change its vaccine approval process, alleging that COVID-19 vaccination resulted in the deaths of 10 children.Video above: ...

In Darwinian terms, survival isn’t a matter of being the biggest, the fastest, or the strongest of the species, but instead ...