NEVADA MPJE QUESTIONS AND ANSWERS 100% PASS

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NEVADA MPJE QUESTIONS AND ANSWERS 100% PASS Laws vs. Regulations ✔✔laws - enacted through a federal or state legislative process regulations - (or rules) provide specific details to help implem... ent the law, and are issued by state regulatory agencies (e.g. state board of pharmacy) FDA Drug Approval Process ✔✔1) pre-clinical testing (animals) 2) manufacturer files an investigational new drug (INDA) application with the FDA 3) INDA approval --> begin Phase 1 study, Phase 2, then Phase 3 4) file a new drug application (NDA) or biologic license application (BLA) to FDA 5) If drug approved, phase 4 study (post-marketing surveillance) Phase 1 study ✔✔assesses safety and adverse effects, as well as PK and PD profile. Small number of healthy subjects (~20-80) Phase 2 study ✔✔focuses on safety and efficacy. subjects have the indicated condition (~35- 100). dose ranging analyzed to determine optimum dose Phase 3 study ✔✔determines efficacy for treating the condition compared to a placebo or goldstandard treatment. larger number of patients (~300-3000) Phase 4 study ✔✔(post-marketing surveillance). conducted after the drug is approved and released for use. can be requested by the FDA or initiated by the manufacturer. can be used to monitor special populations or long-term effects of drug exposure FDA Drug Approval Time ✔✔- the NDA or BLA is evaluated by the FDA through the Center for Drug Evaluation and Research (CDER) - CDER is expected to review 90% of applications for standard drugs within 10 months of receiving the application, and within 6 months for priority drugs Prescription Drug User Fee Act (PDUFA) ✔✔FDA was given authority to collect fees from the "user" (drug manufacturer) in order for the FDA to review [Show More]

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