Term
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Definition
| What is intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man or other animals? |
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Term
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Definition
| What is any virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic produt, or analogous product applicable to the prevention or treatment or cure of a disease or condition in human beings? |
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Definition
| What is an instrument, apparatus, implement, machine, contrivance, implant, in vitro agent, recognized by the official phamacopeias and formularies and used for drugs except that the product does not achieve its intended purpose thru chemical action within or on the body and it is not metabolized? |
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Term
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Definition
| Crutches, electrodes, pacemakers and catheters are all examples of what? |
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Term
| FDA- Food and Drug Administration |
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Definition
| What regulates teh approval process for drugs, biologics and devices? |
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Term
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Definition
| From 1938-1962 what was the main concentration of drug development? |
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Term
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Definition
| In what year did drug efficacy become a consideration? |
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Term
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Definition
| During what years did Generic drugs come out? |
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Term
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Definition
| What was the big concern in the 2000's in drug development? |
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Term
| Supplemental New Drug Application |
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Definition
| What must me completed when approval is sought for an additional indication for a drug already approved for another indication? |
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Term
| Abbreviated New Drug Application |
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Definition
| Which application encourages manufacturors to provide generic versions of pioneer drugs which have lost pt status and reverted to the common domain? |
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Term
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Definition
| What is a drug used for the diagnosis, treatment or prevention of a disease or condition affecting less than 200,000 ppl in the U.S.? |
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Term
| Expanded Access to Unapproved Therapies |
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Definition
| What provisions provided the specific statutory authority to make investigational drugs available in an emergency situation? |
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Term
| The physician under whom the drug is being administered |
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Definition
| Who would be the investigator in a situation where an investigational drug is being used for expanded access? |
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Term
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Definition
| The name "ACE Inhibitor" would be considered what kind of name? |
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Term
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Definition
| What is the official non-proprietary name provided by the U.S. Adopted Name Council? |
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Term
| Brand Name (Trademarked Name) |
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Definition
| What is the non-official name provided by the poineer pharmaceutical company? |
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Term
| legend drug (Prescription) |
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Definition
| What type of drug does the federal law prohibit dispensing without a prescription? |
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Term
| Over-the-Counter drugs (OTC) |
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Definition
| What type of drugs do not require a prescription and are suitable for self-medication? |
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Term
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Definition
| What act encouraged the development of new innovator drugs by extending patent rights and established procedures facilitating the approval of low-cost generic drugs? |
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