NEVADA MPJE LATEST UPDATE GRADED A+

NEVADA MPJE LATEST UPDATE GRADED A+ Laws vs. Regulations laws - enacted through a federal or state legislative process regulations - (or rules) provide specific details to help implement 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 gold- standard 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 the new drug applications and supplements. the funds are used to hire reviewers to help expedite the review process OTC Drug Approval Process either approved thru NDA process used for Rx's or can be approved thru the simpler OTC drug monograph process ("three-phase public rulemaking process") Generic Drug Approval Process must complete an Abbreviated New Drug Application (ANDA). does not require pre-clinical animal studies and clinical studies w/ human subjects. requires a simpler bioequivalency analysis between the generic and the Reference Listed Drug Drug Advertising (Rx and OTC) Rx - regulated primarily by the FDA OTC - regulated primarily by the Federal Trade Commission (FTC) - Direct-to-consumer advertising is not federally legislated and FDA pre-approval is not required Sherman Antitrust Act of 1890 attempted to outlaw monopolies that blocked competition by nefarious methods, such as price-fixing, deceptive marketing practices, and excluding competition from markets Pure Food and Drug Act of 1906 (the Wiley Act) -the first legislation in the U.S. that offered protection to consumers from drug misuse. -mandated accurate product labeling -ingredients used in drugs meet the standards of