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 ...

Learn how an Abbreviated New Drug Application (ANDA) helps generic drugs get FDA approval without clinical trials, ensuring safety and bioequivalence with brand-name drugs.

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 ...

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 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 ...

The U.S. Food and Drug Administration will take steps to streamline the process to develop generic versions of complex biological drugs, the agency announced Wednesday. The changes are meant to ...

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 ...

Representatives of companies including AbbVie, Eli Lilly, Johnson & Johnson and Merck have voiced concerns about the FDA’s approach to pre-approval inspections.

Discover how drugs prevent, cure, and alleviate ailments. Learn about over-the-counter vs. prescription drugs and the ...