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.)
