Please refer to the sections below if you have questions on how to navigate FDA's Bringing an Unapproved Drug into Compliance course. It will take approximately 90 minutes to complete the course and there are no bookmarking features, therefore, if you plan to complete the course in multiple sessions, please take note of where you are when you leave the course.
Technical Setup
Before starting, please ensure your computer has both the required software and the recommended settings to view the course. This information can be found in the Technical Support link at the bottom right of the screen or by clicking here.
Bandwidth Selection
This training is presented in two available forms - a high bandwidth version and a low bandwidth version. The training is identical in form and content. We suggest users with a broadband or high-speed internet connection choose the high bandwidth version, whereas users with dial-up access should choose the low bandwidth version.
Navigation
To access the various modules in the training, select the desired module from the top of the page (Scenario, Introduction, Approval Pathways, Decision Tree, Getting Started, Resources). After the module has been selected, a list of topics will appear on the left.
The module will automatically begin and auto-advance you through the course. You may select any of these topics to go directly to the corresponding section of the training.
Clicking one of the five buttons across the bottom (Drugs Home, CDERLearn Home, Unapproved Drugs Home, Course Home, Technical Support) will guide you directly to the corresponding website.
You may also click Back or Next in the lower right corner to navigate forward or back in the training.
The play and pause buttons are in the same location below the video. They toggle based on the current status of the training. Click on the pause button to pause and the play button to play.
In order to scroll through the video, the entire video must fully load. After the video has loaded you can scroll to specific sections of that video by sliding the white triangle back and forth. Please be patient, because sometimes it takes certain videos longer to load than others.
Keyboard Shortcuts
Throughout the training, the following keyboard shortcuts are in place:
- b - Navigate backward in the training.
- n - Navigate forward in the training.
- p - Play/Pause the video.
You'll need a Standard 101/102-Key or Natural PS/2 Keyboard to use the shortcuts.
Accessibility
When using a screen reader, you may select Skip to Module Navigation to allow you to choose a module, Skip to Topic Navigation to allow you to select topics within a module, or Skip to Content to go directly to the content for that module.
To toggle the audio transcript on/off, select Toggle Audio Script.
To toggle the audio transcript on/off, select either Turn Audio Script On or Turn Audio Script Off.
Auto-Advance Feature
The course is set up to automatically advance you to the next topic and the next module. You may turn this feature off by clicking Turn Off Auto-Advance.
Topic and Course Progress
In the lower left corner of the screen your progress is shown for both your position in the current module, as well as your position in the entire course. The topic progress numbers correlate to where you are in that specific module (i.e., Topic 3 of 7 in the Decision Tree Module). The course progress numbers correlate to where you are in the entire course (i.e., If you are on Course 30 of 53, you know that you have completed over half of the course.)