The purpose of this exercise is to introduce you to the Food, Drug and Cosmetic Act.
Take a look at the WebEx Resource: Food, Drug and Cosmetic Act. This document is an expanded table of contents of the federal Food, Drug and Cosmetic Act. It will help you identify what sections you may want to search for information that you are seeking. In time, as a regulatory professional, you will become familiar with various sections relevant to your work. Take a few minutes to browse a bit through this expanded table of contents to get an overview of the categories and sections it contains.
View the Web Resource: Food, Drug and Cosmetic Act. You’ll notice that the Web Resource: Food, Drug and Cosmetic Act lists the section number and titles. This can be very useful.
Now go to the Food, Drug and Cosmetic Act on the FDA website: https://www.fda.gov/regulatoryinformation/lawsenforcedbyfda/federalfooddrugandcosmeticactfdcact/default.htm. You’ll notice that on the left of the homepage for the Act is a table of contents similar to our Web Resource. Note that there is no search mechanism, so there is no way to search the entire online Act for a particular phrase. However, you could search individual webpages and this is an advantage over the print version of the document.
Let’s practice searching for something within the Act. Let’s say you need to find out what the legal requirements are for an application for premarket approval for a Class III device. How do you quickly find the information you need?
Practice Exercise:
• Step 1: Go to the Food, Drug and Cosmetic Act homepage.
• Step 2: Click on Chapter V: Subchapter A – Drugs and Devices, and scroll down to find the Section titled “Premarket Approval”. Note that it is FD&C Act 515, which corresponds to 21 USC Sec 360e – Premarket Approval
• Step 2: Click on “Office of Law Revision Counsel, search by U.S. code section number” in the blue box at the top of the page
• Step 3: Click on “Advanced Search” on the top right-hand corner of the page
• Step 4: Type in “Application for Premarket Approval” in the General Search Terms field
• Step 5: In the “Search In” field, type “21” under Title and “360e” under Section, and click Search or Enter
• Step 6: Click on the result at the bottom of the page and find the “Application for Premarket Approval” section. In the paragraphs below this heading, it details the seven things that should be in such an application, beginning with “full reports of all information, published or known to or which should reasonably be known to the applicant, concerning investigations which have been made to show whether or not such device is safe and effective.”
Alternatively, you can just go to the Office of Law Revision Counsel, United States Code Advanced Search, and type in “Application for Premarket Approval” in the General Search Terms to perform a more general search of the entire FD&C Act.
Using the WebEx Resource: Food, Drug and Cosmetic Act and the Food, Drug and Cosmetic Act homepage, answer the following questions. It may be helpful to print this page to use as a reference while you are conducting your information search.
- Name two things that ought to be on its package label and whose absence could cause a drug or device to be deemed misbranded?
- What is the maximum number of patients allowed to grant a drug designation for a rare disease?
- Accelerated Approval of a fast track product may be subject to two requirements:
- For what activities regarding tobacco products does FDA coordinate with the Federal Trade Commission (FTC)?
Sample Solution
