Aug 12, 2024 · The FDA has authority to grant orphan drug designation to a drug or biological product to prevent, diagnose or treat a rare disease or condition.

This page searches the Orphan Drug Product designation database. Searches may be run by entering the product name, orphan designation, and dates. Results can be displayed as a …

In order to designate a product as an orphan drug, the scientific rationale portion of the designation application must include enough information to establish a medically plausible …

For a complete list of orphan drug designations and approvals see the searchable Orphan Products Designation Database. FDA considers ovarian cancer, fallopian tube cancer, and …

(10) Orphan drug means a drug intended for use in a rare disease or condition as defined in section 526 of the act. (11) Orphan-drug designation means FDA's act of granting a request …

The ODA amends the Food, Drug, and Cosmetic Act (FDCA) to create two primary mechanisms to encourage orphan drug development: orphan-drug designation (described in 42 U.S.C. § …

Where is OOPD within FDA? The mission of OOPD is to advance the evaluation and development of products that demonstrate promise for the diagnosis and/or treatment of rare …

Aug 2, 2024 · Obtaining Orphan Drug Designation is a detailed and strategic process that requires careful planning and execution. The designation not only facilitates drug development with …

Over the past decades, US Congress enabled the US Food and Drug Administration (FDA) to facilitate and expedite drug development for serious conditions filling unmet medical needs …

We found 5,099 orphan drug designations representing 3,269 unique products, of which 508 had an orphan-designated approval from FDA. Unique products with only a single designation …