Industry Information and Guidance

Learn more about FDA’s resources to provide manufacturers with information on the review and approval process for biosimilar and interchangeable products.Guidance for IndustryFDA provides guidance on demonstrating biosimilarity and interchangeability, biosimilar...

FDA Drug Safety Communication

[04-15-2011] To further evaluate the safety of Long-Acting Beta-Agonists (LABAs) when used in combination with inhaled corticosteroids for the treatment of asthma, the U.S. Food and Drug Administration (FDA) is requiring the manufacturers of LABAs to conduct five...