Tag: generic drugs
FDA Regulatory Authority: How the Agency Approves Generic Drugs
The FDA approves generic drugs through the ANDA process, ensuring they are bioequivalent to brand-name drugs without repeating clinical trials. This system saves billions annually and makes medications affordable for millions.
Future Role of Authorized Generics: Market Outlook
Authorized generics are brand-name drugs sold under a generic label. As patents expire on high-revenue drugs, their role in pricing and competition is shifting - with new FDA policies and domestic manufacturing incentives changing how they’re used.