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Department of Health and Human Services Food and Drug AdministrationFDA ORPHAN DRUG DESIGNATION REQUEST FORMForm Approved OMB Control Number: 09100167 Expiration Date: January 31, 2021 See OMB Statement.

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Orphan Drug Designation Request Form | FDA
May 19, 2021 — The content and format of a request for orphan drug designation is...
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7-year marketing exclusivity to sponsors of approved orphan products. 25% federal tax credit for expenses incurred in conducting clinical research within the United States. ... Waiver of Prescription Drug User Fee Act (PDUFA) fees for orphan drugs.

Listen to pronunciation. (OR-fun ) A drug used to treat, prevent, or diagnose an orphan disease. An orphan disease is a rare disease or condition that affects fewer than 200,000 people in the United States.

The orphan designation is part of the approval process In fact, the orphan application can be filed anytime in the drug development process before NDA/BLA submission, even prior to IND filing.

Criteria for Orphan Drug Designation The product must be intended for use in a rare disease or condition. Adequate documentation or prevalence data must demonstrate that the intended condition is rare.

An orphan drug can be defined as one that is used to treat an orphan disease. For example, haem arginate, used to treat acute intermittent porphyria, variegate porphyria, and hereditary coproporphyria [12], is an orphan drug.

Orphan Drugs receive a 7-year period of exclusivity from product approval - effective on the date of FDA approval of a marketing application. For seven years, FDA will not approve a subsequent sponsor of the same drug for the same use or indication (except as otherwise provided).

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 one that affects less than 200,000 persons in the US" (which equates to approximately 6 cases per 10,000 population) "or meets cost ...

Mail the CD along with a signed cover letter as described at Corresponding with the OOPD Drug Designation Programs. Alternatively, during this public health emergency associated with the COVID-19 pandemic, orphan designation requests may be submitted by email to orphan@fda.hhs.gov.

The orphan designation is part of the approval process In fact, the orphan application can be filed anytime in the drug development process before NDA/BLA submission, even prior to IND filing.

A sponsor seeking orphan designation for a drug must submit a request for designation to OOPD with the information required in 21 CFR 316.20 and 316.21. Each designation request must stand on its own merit.

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© Copyright 1997-2025
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Form Packages
Adoption
Bankruptcy
Contractors
Divorce
Home Sales
Employment
Identity Theft
Incorporation
Landlord Tenant
Living Trust
Name Change
Personal Planning
Small Business
Wills & Estates
Packages A-Z
Form Categories
Affidavits
Bankruptcy
Bill of Sale
Corporate - LLC
Divorce
Employment
Identity Theft
Internet Technology
Landlord Tenant
Living Wills
Name Change
Power of Attorney
Real Estate
Small Estates
Wills
All Forms
Forms A-Z
Form Library
Customer Service
Terms of Service
DMCA Policy
About Us
Blog
Affiliates
Contact Us
Privacy Notice
Delete My Account
Site Map
Industries
Forms in Spanish
Localized Forms
State-specific Forms
Forms Kit
Legal Guides
Real Estate Handbook
All Guides
Prepared for You
Notarize
Incorporation services
Our Customers
For Consumers
For Small Business
For Attorneys
Our Sites
US Legal Forms
USLegal
FormsPass
pdfFiller
signNow
airSlate workflows
DocHub
Instapage
Social Media
Call us now toll free:
1-877-389-0141
As seen in:
  • USA Today logo picture
  • CBC News logo picture
  • LA Times logo picture
  • The Washington Post logo picture
  • AP logo picture
  • Forbes logo picture
© Copyright 1997-2025
airSlate Legal Forms, Inc.
3720 Flowood Dr, Flowood, Mississippi 39232