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IHP600 SNHU FDA Legislations

Pick two topics the FDA Legislations1906Food and Drugs Act: FDA is authorized to take action only after drugs sold to consumers cause harm.1938Federal Food, Drug, and Cosmetic Act: Evidence of safety is required before new drugs or devices can be marketed.1962Drug Amendments: FDA takes charge of reviewing efficacy and safety of new drugs, which can be marketed only once approval is granted.1976Medical Devices Amendments: Premarket review of medical devices is authorized; devices are grouped into three classes.1983Orphan Drug Act: Drug manufacturers are given incentives to produce new drugs for rare diseases.1990Safe Medical Devices Act: Health care facilities must report device-related injuries or illness of patients or employees to the manufacturer of the device and, if death is involved, the incident must also be reported to the FDA.1992Prescription Drug User Fee Act: FDA receives the authority to collect application fees from drug companies to provide additional resources to shorten the drug approval process.1997Food and Drug Administration Modernization Act: Fast-track approvals for life-saving drugs are permitted when their expected benefits exceed those of existing therapies.The topics are located above.

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