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GRLR Project

Version 10

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)

1. 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)

2. 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 own words. For example: Are the references relevant to your search? Are they robust and solid scientific references? Do the references increase or decrease your confidence in the AI response?>

If you use additional prompts, capture this same information for subsequent prompts.

2.b. Interpretation

Based on your research, and in your own words, explain why you think there is less oversight for each product, and if you feel the amount of oversight is sufficient for each product.

(
Hint: See the assignment rubric below to ensure that you are providing a complete answer.)

Product Example

Why is there less oversight than a pharmaceutical?

Is the level of oversight sufficient? Why or why not?

Grading Comments for Question 1

Score for Question 1

(Possible 5)

Grading Comments for Question 2a and 2b

Score for Question 2

(Possible 5)

Rubric:

Does not meet requirements

Some requirements met

Good

Excellent

Question 1

No engagement/effort with this question. (0)

Use of AI (0)

The student only answered part of the question, and/or is not clear on what drove the need for change, and how that change decreased risk. (1-2)

The student explained the evolution and the changes made to FDA authority, but was not able to articulate how this new authority decreased risk. (3-4)

The student understood the heightened risk and concern related to lack of FDA authority. Understood the evolution of the changes. (5)

Question 2a

No engagement/effort with this question. (0)

Inappropriate use of AI, requested information not provided (0)

The student provided some but not all of the requested information in the research section. (1)

The student provided information from research but was not able to articulate a balanced assessment of the AI responses and references. (1.5)

The student provided information from research and provided a balanced assessment of AI response and references. (2)

Question 2b

No engagement/effort with this question. (0)

The student was not able to find 2 products as described, or incorrectly identified products. (1)

The student found 2 products correctly, but did not understand why there is less oversight. (2)

The student found 2 relevant examples, understood why there is less FDA oversight, and provided their position and rationale. (3)

Marla A. Phillips, Ph.D. | CEO and President | Pathway for Patient Health

[email protected] | 513-238-4338 | www.Pathway4PH.org

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