Homework Assignment 1
Pathway for Patient Health
Global Regulatory and Legal Requirements of Quality
| Complete this assignment by typing your answers into this Word document |
First Name:
Last Name:
Email address:
- Save this file as: First Name Last Name GRLR Project 1 (e.g. Marla Phillips GRLR Project 1.doc)
- Submit this assignment in Canvas
- Assignment due dates listed in the syllabus.
- Note, as generative AI can be a helpful tool to assist our learning process, there are specific instances where the assignments will allow specific AI use. You may only use AI, within an assignment, when asked to do so and you must capture the requested information.
| This assignment must be submitted by the due date that was provided to you by 11:59pm (EST) |
- Complete the following table related to the history of FDA regulations:
(Hint: See the assignment rubric below to ensure that you are providing a complete answer.)
| Legislation | Description of how the legislation took steps to improve public safety | Despite the legislation, what limitations to FDA authority still existed? |
| 1906 Food and Drug Act |
|
|
| 1912 Sherley Amendment | ||
| 1938 Federal Food, Drug and Cosmetic Act | Optional | 0.5-point extra credit | Describe a limitation and cite objective evidence for it (i.e., data source) | |
| 1962 Kefauver-Harris Amendments | Optional | 0.5-point extra credit | Describe a limitation and cite objective evidence for it (i.e., data source) |
- Research 2 examples of products from 2 different life science industries you can buy today that have less FDA oversight and approval than a pharmaceutical prescription drug. Note for your research in answering this question, you will use generative AI. Complete 2.a. Research and 2.b. Interpretation.
2.a. Research
For this assignment research using generative AI, use the prompt identified below and capture all requested information:
Generative AI system used, including version: <e.g. Gemini with 2.0 flash>
Prompt to use: What products does the FDA regulate?
Copy and paste response here:
<capture text response here>
Discussion of response:
<Discuss in your own words if you think the response was relevant to what we are talking about.>
List any references cited in the AI response: (Note: If the generative AI did not provide sources, enter a second prompt: “Can you provide specific citations for this answer?”)
<Capture any references or links cited or provided with the AI response.>
Discussion of references:
<Discuss your thoughts on the references in your
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