Keyword Analysis & Research: orphan drug designation
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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 can be displayed as a condensed...
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Designating an Orphan Product: Drugs and Biological Products
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.
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Frequently Asked Questions (FAQ) About Designating an Orphan …
https://www.fda.gov/industry/designating-orphan-product-drugs-and-biological-products/frequently-asked-questions-faq-about-designating-orphan-product
WebMay 11, 2023 · Designation is given to a drug or biologic for the treatment, diagnosis or prevention of a rare disease or condition. See below for frequently asked questions about submitting requests for...
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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 condition the...
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Orphan drug - Wikipedia
https://en.wikipedia.org/wiki/Orphan_drug
WebIn the U.S., orphan drug designation means that the sponsor qualifies for certain benefits, but it does not mean the drug is safe, effective or legal. In 2002, the Rare Diseases Act was signed into law. It amended the Public Health Service Act to …
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Orphanet : Search for an orphan drug
https://www.orpha.net/en/drug
WebOrphan designation is a legal procedure that allows for the designation of a medicinal substance with therapeutic potential for a rare disease, before its first administration in humans or during its clinical development. The exact therapeutic indication is then defined at the time of marketing authorisation.
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Orphan designation: Overview | European Medicines Agency
https://www.ema.europa.eu/en/human-regulatory-overview/orphan-designation-overview
WebEMA is responsible for reviewing applications from sponsors for orphan designation. To qualify for orphan designation, a medicine must meet a number of criteria: it must be intended for the treatment, prevention or diagnosis of a disease that is life-threatening or chronically debilitating;
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Orphan Drug Approval Laws - StatPearls - NCBI Bookshelf
https://www.ncbi.nlm.nih.gov/books/NBK572052/
WebJun 5, 2023 · The Orphan Drug Approval Law of 1983 incentivized pharmaceutical companies to develop drugs for rare diseases by offering market exclusivity and tax credits. This activity reviews the history of the Orphan Drug Approval Law and discusses associated ethical concerns and clinical significance. Objectives:
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What Is the Orphan Drug Status, and When Is It Designated ... - GoodRx
https://www.goodrx.com/drugs/medication-basics/orphan-drug-status
WebSep 10, 2021 · An orphan drug (OD) is a medication used for the diagnosis, prevention, or treatment of a rare disease — a medical condition that isn’t common but can be serious or life-threatening.
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eCFR :: 21 CFR Part 316 -- Orphan Drugs
https://www.ecfr.gov/current/title-21/chapter-I/subchapter-D/part-316
Web§ 316.2 Purpose. The purpose of this part is to establish standards and procedures for determining eligibility for the benefits provided for in section 2 of the Orphan Drug Act, including written recommendations for investigations of orphan drugs, a 7-year period of exclusive marketing, and treatment use of investigational orphan drugs.
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