Term
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Definition
| to ensure that they are safe and effective for their intended uses; and that labeling and packaging is truthful, informative, and not deceptive |
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Term
| What was Thalidomide used for when it was first put on the market? |
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Definition
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Term
| What body parts were adversely affected in thalidomide's embryopathy? |
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Definition
| upper and lower limbs, ears and eyes, and internal organs |
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Term
| What biologic was administered in the failed lab experiment that produced Tegenero's cytokine storm? |
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Definition
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Term
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Definition
| binds to CD28 and activates T cells (superagonist), resulting in polyclonal T cell activation and expansion as well as IL-2 cytokine production |
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Term
| Describe the study flaw of Tegenero's "cytokine storm"? |
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Definition
| dosing between subjects was seperated by a ten-minute interval in the first human trial |
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Term
| What was the result of Tegenero's cytokine storm? |
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Definition
| all of the subjects were hospitalized and survived but two patients developed prolonged CV shock and ARDS. Also following treatment, a patient had several fingertips and all of his toes amputated |
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Term
| Tegenero's cytokine storm caused what policy changes? |
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Definition
| special consideration for drugs whose effects can not be demonstrated in animals; broader approach to determining the clinical starting dose besides just looking at NOEL or NOAEL |
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Term
| What general study information is gathered by phase I studies? |
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Definition
| human pharmacology, safety, and tolerability issues |
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Term
| What general study information is gotten from phase II studies? |
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Definition
| explore therapeutic efficacy despite the narrow patient population |
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Term
| What study information is gotten from phase III trials? |
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Definition
| cofirm therapeutic efficacy with a wider patient population |
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Term
| What information is gathered from phase IV trials? |
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Definition
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Term
| Phase I-IV clinical trials are conducted under a _______ application. |
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Definition
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Term
| What are the primary objectives in reviewing an IND? |
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Definition
| assure the safety and rights of subjects, to help assure quality of the scientific evaluation of drugs is adequate and to permit an evaluation of the drug's effectiveness and safety |
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Term
| What happens after the FDA recieves an IND? |
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Definition
| the FDA either allows the protocol to proceed or issues a clinical hold within 30 days of receiving the applications |
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Term
| An investigative new drug for which an IND is in effect is exempt from... |
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Definition
| premarketing approval requirements |
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Term
| For what types of reasons can an IND application be put on hold? |
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Definition
| human subjects are at risk, study is not well designed, investigator isn't qualified |
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Term
| What is an NDA application for? |
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Definition
| obtain marketing approval for drugs |
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Term
| What is an original application? |
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Definition
| pending application that FDA hasn't issued a complete response letter or approval letter to; or an appilication that was submitted again after the agency refused to file it or after it was withdraw without being approved |
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Term
| What is the 505(b)(2) application? |
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Definition
| when you are relying on someone elses data to get your drug approved |
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Term
| What are BLA applications? |
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Definition
| applications to obtain marketing approval for biologic products subject to licensure |
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Term
| T/F Applicants must provide a resubmission that addresses ALL of the deficiencies identified in the "complete response letter" in order to obtain marketing approval. |
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Definition
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Term
| Challenges in regulating drugs involves protecting consumers from... |
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Definition
| adverse effects of unapproved drugs, exposure to counterfeit drugs, and complications resulting from a "recall" |
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Term
| What types of things can the FDA recall? |
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Definition
| drugs, biologics, medical devices, food |
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