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What is required for orphan drug designation?

The Orphan Drug Act defines a rare disease or condition as one (a) that affects fewer than 200,000 persons in the United States or (b) for which there is no reasonable expectation that the cost of developing a drug and making it available in the U.S. will be recovered from sales in the country.

What does not FDA approved for orphan indication mean?

Orphan Drug Status Orphan status does not mean that FDA has approved the drug. Orphan. status and FDA approval are not the same. The approval of an orphan designation request does not alter the standard regulatory requirements and process for obtaining marketing approval.

How do I submit an orphan drug designation request?

Requests for an orphan drug designation can be submitted through the FDA Form 4035. The FDA will complete a review of the orphan drug designation request within 90 days of its receipt. The components required for submission of Form 4035 include: Information about the sponsor and drug product.

When do you submit orphan drug designation?

(a) A sponsor may request orphan-drug designation at any time in its drug development process prior to the time that sponsor submits a marketing application for the drug for the same rare disease or condition.

What is the FDA orphan drug designation 200000?

The Orphan Drug Act defines a rare disease as a disease or condition that affects less than 200,000 people in the United States.

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What is the FDA form for orphan drug designation?

The Form FDA 4035 is designed to assist sponsors in providing the required content completely and succinctly for orphan drug designation requests. If you receive a Please wait message when you click on the Form FDA 4035, go to the upper right download arrow and download the form.

How do I submit an orphan drug annual report?

Contact orphan@fda.hhs.gov to: Request a meeting. Submit an orphan drug, rare pediatric disease or humanitarian use device designation request. Submit changes to your contact information.

How do I submit an orphan drug designation to the FDA?

Orphan drug requests can be submitted by email to orphan@fda.hhs.gov. Please include a dated and signed cover letter, a bibliography and full copies (not abstracts) of all references cited. See Designating an Orphan Product: Drugs and Biological Products for more information.

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