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People also ask
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What is an example of indication for use?
“Indications for Use” can be defined as “what circumstances or what conditions you would use that particular product or device.”2. Examples of this include the conditions the device was designed to diagnose, treat, prevent, cure, or mitigate, as well as a description of the target patient population. -
What is the FDA criteria for orphan drugs?
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 are the requirements for the Orphan Drug Act?
To obtain an orphan designation, sponsors must submit an application to the Office of Orphan Products Development that contains details on the rare disease for which the drug will be investigated, the specific indication for the drug, a description of the drug, documentation of disease prevalence, and the regulatory ... -
What is the US orphan drug threshold?
ing 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 ... -
What is an example of an intended use statement?
As an example, let's say you've got a new scalpel you'd like to get to market. You'll find if its intended use is stated for cutting of flesh (in general terms), it will be a Class I device, yet if it is stated as being specifically for use on an eyeball, it will be Class III. -
What is the FDA guidance on orphan drug development?
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 qualifies sponsors for incentives including: Tax credits for qualified clinical trials. Exemption from user fees. -
What is the difference between intended purpose and indications for use?
In a nutshell, the definitions for intended use and indications are as follows: Intended use is what you claim on your label that the device does. It's the purpose of your device. Indications for use are the circumstances or conditions under which the device will be used. -
What is the US orphan drugs Act?
In 1983, the United States Congress passed the Orphan Drug Law Act (ODA), which incentivized pharmaceutical companies to develop drugs aimed specifically at treating rare diseases.
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