A Simple Guide to the FDA Application Form: What You Need to Know

When it comes to launching food, drug, cosmetic, or medical products in the United States, the FDA application form is your official gateway. Whether you're a manufacturer, distributor, or importer, getting FDA approval isn’t just a box to tick—it's a legal requirement that protects public health and builds trust in your product. But if you're staring at that application wondering where to begin, don’t worry. Here’s a quick, no-nonsense guide. What Is the FDA Application Form? The FDA (Food and Drug Administration) application form is a formal document used to apply for the approval or registration of products regulated by the FDA. It varies depending on the product category (like food, drugs, medical devices, or cosmetics). Some common FDA forms include: Form 356h – Application to market a new drug or biologic Form 1571 – Investigational New Drug (IND) application Form 2253 – Promotional labeling and advertising Form 2656 – Registration of food faci...