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 ...

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 ...

In the first year of the second Trump administration, we have seen the Food and Drug Administration (FDA) take an ...

The U.S. Food and Drug Administration (FDA) announced on Wednesday (October 29) a plan to streamline the approval process for biosimilars, which are generic versions of complex biological drugs. These ...

Sept 3 (Reuters) - The U.S. Food and Drug Administration on Wednesday proposed a new process to streamline the approval of drugs targeting rare diseases with very small patient populations, including ...

The Food and Drug Administration on Thursday selected nine drugs for expedited reviews intended to speed up the approval process. Why it matters: The awarding of the new priority review vouchers is a ...

An FDA draft guidance nixing the requirement for biosimilar manufacturers to conduct comparative efficacy studies may prove ...

Milestone Pharmaceuticals, a Canadian company with a U.S. subsidiary in Charlotte, is starting the new year with its first ...