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Designating an Orphan Product: Drugs and Biological Products | FDA
https://www.fda.gov/industry/medical-products-rare-diseases-and-conditions/designating-orphan-product-drugs-and-biological-products
WEBThe 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 …
DA: 27 PA: 56 MOZ Rank: 17
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Search Orphan Drug Designations and Approvals
https://www.accessdata.fda.gov/scripts/opdlisting/oopd/
WEBThis page searches the Orphan Drug Product designation database. Searches may be run by entering the product name, orphan designation, and dates. Results …
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Frequently Asked Questions (FAQ) About Designating an Orphan Prod…
https://www.fda.gov/industry/designating-orphan-product-drugs-and-biological-products/frequently-asked-questions-faq-about-designating-orphan-product
WEBMay 11, 2023 · FDA may grant orphan drug designation to a drug that is otherwise the same drug as a drug already approved in the U.S. for the …
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Orphan Drug Designation: Disease Considerations | FDA
https://www.fda.gov/industry/designating-orphan-product-drugs-and-biological-products/orphan-drug-designation-disease-considerations
WEBWhen reviewing a request for orphan drug designation, FDA considers the mechanism of action of the drug to determine what distinct disease or …
DA: 33 PA: 13 MOZ Rank: 60
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eCFR :: 21 CFR Part 316 -- Orphan Drugs
https://www.ecfr.gov/current/title-21/chapter-I/subchapter-D/part-316
WEBThis part sets forth the procedures and requirements for: ( 1) Submissions to FDA of: ( i) Requests for recommendations for investigations of …
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