Mar 13, 2025 · Understanding generic drugs. Consumer-friendly information on the safe and effective use of generic drugs.

Generic Drug Facts At-a-glance information on generic medicines, including why they may look different or cost less than brand-name medicines.

Oct 23, 2025 · FDA considers first generics to be important to public health, and prioritizes review of these submissions.

Nov 1, 2021 · Generic drugs: Get the facts. Consumer-friendly text and graphics provide a few facts about generic drug approval, quality, and performance.

Sep 16, 2025 · The FDA Office of Generic Drugs follows a rigorous review process to make sure that, compared to the brand-name (or innovator) medications, the proposed generic medications: Contain …

Generics (typically small molecules) and biosimilars (typically larger, more complex molecules) are approved through different abbreviated pathways that avoid duplicating certain costly clinical ...

Nov 22, 2024 · Generics of complex brand name drugs (i.e., reference listed drugs) can be more difficult to develop. As such, a complex drug may be less likely to have an available generic.

This list of authorized generic drugs (AGs) was created from a manual review of FDA’s database of annual reports submitted to the FDA since January 1, 1999 by sponsors of new drug applications ...

Sep 17, 2025 · A 2-day hybrid workshop focused on exploring the opportunities, applications, and regulatory considerations of AI in generic drug development.

The FDA List of Authorized Generics page answers what an authorized generic is and how it differs from a traditional generic. An authorized generic is used to describe an approved brand name drug ...