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.

ADMA Biologics receives FDA approval for a process enhancing plasma production yields by 20%, boosting growth and capacity for its products. ADMA Biologics, Inc. has announced the U.S. FDA approval of ...

A strict new vaccine approval process in the U.S. could dramatically slow things down for biopharma and the public, experts ...

Americans rely on the Food and Drug Administration to make sure that medical devices are safe. Reporting by KFF Health News has raised questions about how the FDA has dealt with some products, ...

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

A cannabinoid drug candidate for the treatment of Autism Spectrum Disorder is being explored by in trials, led by Ajna BioSciences, Charlotte's Web, and British-American Tobacco in a joint venture ...

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: ...

April 9, 2010 — In its latest effort to reduce the risks of medical radiation, the US Food and Drug Administration (FDA) yesterday notified manufacturers of radiotherapy equipment such as linear ...