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10 Cards in this Set
- Front
- Back
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What is the Federal Food, Drug, and Cosmetic Act? |
Proposed in 1933 to protect consumers 1937- Public outcry due to >100 deaths from improperly prepared sulfanilamide Passed by Congress in 1938 Created the FDA (Food and Drug Administration) Establishes classes of drugs Prescription vs non-prescription |
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What is an IND? |
Investigational New Drug Application Based on preliminary testing completed on animals Basis of proposing human research |
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The IND Appraisal by the FDA is done in conjunction with what? |
A local institutional Review Board (IRB) Appraisal |
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What does an IRB examine? |
The specifics of a clinical trial, consent issues, patient protection |
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What is the FDA drug approval process? |
Drug developed and animals tested > IND application > Clinical trials (phase I, II, and III) |
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What is the impact of the FDA? |
Frances Oldham Kelsey (FDA scientist) kept thalidomide off the U.S. market |
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What happens in Phase I trials? |
Involves 20-80 healthy subjects Focus on identifying frequent side effects Drug metabolization and excretion is studied |
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What happens in phase II trials? |
24 to 300 subjects with the disease Focus on effectiveness of new compound Comparison of drug vs placebo Gathers data on safety and side effects |
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What happens in phase III trials? |
FDA and drug sponsor agree on structure of phase III trials 100 to 3,000 subjects Different dosages and drug interactions studied Safety and effectiveness data continues to be collected and evaluated |
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What is an NDA? |
New drug application Submitted with data from completed studies Takes 6 to 10 months Package Insert (PI) submitted for approval and may require revision |
