Exam (elaborations)
Reg Affairs definitions exam 1 (1).
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Reg Affairs definitions exam 1 (1).
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Reg Affairs definitions exam 1Statute - ANS-law or amendment to a law passed by congress
regulation - ANS-rule issued by a federal agency
orphan drug - ANS-drug for a disease/condition which is rare (less than 200K in US), no
reasonable expectation that the cost of developing will be recovered- guarantees developer 7
years of market exclusivity following approval
medical device - ANS-any instrument, apparatus, or other article that is used to prevent,
diagnose, mitigate, or treat disease or to affect the structure of function of the body
US code - ANS-official compilation of codified laws by subject
CFR - ANS-official compilation of regulations
drug - ANS-product used in diagnosing, curing, mitigating, treating, or preventing a disease or
affecting a structure or function of the body
serious adverse event - ANS-any untoward medical occurrence that results in death, is
life-threatening, requires subject hospitalization or prolongation of existing hospitalization,
results in persistent or significant disability or incapability or is a congenital anomaly or birth
defect
authorized generic - ANS-drug product for which there is a licensing agreement between the
innovator company and a generic drug manufacturer
dietary supplement - ANS-product taken by mouth that contains a dietary ingredient intended to
supplement the diet
OTC - ANS-drug product marketed for use by the consumer without a healthcare professional's
intervention
FDA guidance documents - ANS-describe the agency's interpretation of regulatory issues or
policies
citizen petitions - ANS-formal written request to FDA asking the agency to take or refrain from
taking an administrative action
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