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Pick two of the identified legislations topics below and explain their impact today. 1906 _Food and Drugs Act_: FDA is authorized to take action only after drugs sold to consumers cause harm. 1938 _Federal Food, Drug, and Cosmetic Act_: Evidence of safety is required before new drugs or devices can …
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Pick two of the identified legislations topics below and explain their impact today.
1906
_Food and Drugs Act_: FDA is authorized to take action only after drugs sold to consumers cause harm.
1938
_Federal Food, Drug, and Cosmetic Act_: Evidence of safety is required before new drugs or devices can be marketed.
1962
_Drug Amendments_: FDA takes charge of reviewing efficacy and safety of new drugs, which can be marketed only once approval is granted.
1976
_Medical Devices Amendments_: Premarket review of medical devices is authorized; devices are grouped into three classes.
1983
_Orphan Drug Act_: Drug manufacturers are given incentives to produce new drugs for rare diseases.
1990
_Safe 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.
1992
_Prescription 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.
1997
_Food and Drug Administration Modernization Act_: Fast-track approvals for life-saving drugs are permitted when their expected benefits exceed those of existing therapies.
The assignments must follow these formatting guidelines: double spacing, 12-point Times New Roman font, one-inch margins, and discipline-appropriate citations (APA format). The length requirements: 5 – 7 pages graduate courses. (This does not include the cover page or the reference list.)
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