Designating an Orphan Product: Drugs and Biological Products
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. Orphan drug designation …
Search Orphan Drug Designations and Approvals - Food and Drug …
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 …
Orphan Drug Designation: Disease Considerations | FDA
FDA considers the mechanism of action of the drug to determine what distinct disease or condition the drug is intended to treat, diagnose or prevent.
Office of Orphan Products Development | FDA - U.S. Food and Drug ...
Oct 1, 2024 · Provide orphan status to drugs and biologics which are intended to treat, diagnose or prevent rare diseases that affect fewer than 200,000 people in the U.S.
Search Orphan Drug Designations and Approvals - Food and Drug ...
Search Orphan Drug Designations and Approvals. *Exclusivity Protected Indications are shown for approvals from 01/01/2013 to the present. *Data for the Date Designation Withdrawn or …
eCFR :: 21 CFR Part 316 -- Orphan Drugs
This part sets forth the procedures and requirements for: (1) Submissions to FDA of: (i) Requests for recommendations for investigations of drugs for rare diseases or conditions; (ii) Requests …
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. § …
Expediting treatments in the 21st century: orphan drugs and …
Nov 8, 2024 · In response to activated patient communities’ catalyzation, two significant efforts by the FDA to expedite treatments have now been in place for multiple decades. In 1983, the …
Orphan drug - Wikipedia
According to the US Food and Drug Administration (FDA), an orphan drug is defined as one "intended for the treatment, prevention or diagnosis of a rare disease or condition, which is …
Rare Diseases at FDA | FDA - U.S. Food and Drug Administration
Dec 13, 2022 · Since the Orphan Drug Act was signed into law in 1983, the FDA has approved hundreds of drugs for rare diseases, but most rare diseases do not have FDA-approved …