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.

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 ...

Forbes contributors publish independent expert analyses and insights. Ge Bai is professor of accounting & health policy at Johns Hopkins. Biologic drugs, made from living organisms and usually taken ...

In the American drug industry, a trend has developed among manufacturers and pharmacy benefits managers (PBM) that threatens to upend a productive balance between rewarding manufacturer innovation and ...

The European market for orphan drugs presents many opportunities and challenges for pharma companies. With over 30 million people in the EU living with rare diseases, the demand for innovative ...