It is 2021 and the United States Congress will soon convene to discuss PDUFA reauthorization. During this time the Commissioner of the FDA will go before members of Congress to explain how it can help the Agency to continue fulfilling its mission. Assuming the FDA has properly met its review timelines while collecting user fees from industry, compose a 2-3 page letter to the FDA Commissioner stating why you believe PDUFA should, or should not, be reauthorized. If you believe PDUFA should be renewed, describe any improvements you believe should be made to the previous Act. Remember, the FDA has dual, sometimes opposing responsibilities to protect consumer safety while providing the public access to potentially life-saving treatment. You may write the letter from the perspective of a consumer, a Regulatory Specialist working in industry, or an FDA employee. Background Information: The Prescription Drug User Fee Act was initially authorized in 1992. In exchange for industry user fees, the FDA agreed to follow deadlines imposed for drug review time among meeting other performance standards. PDUFA was renewed in 1997, 2002, 2007, 2012, 2017. Over the past two decades, annual user fees- which make up a large portion of FDA funding- have increased substantially as the average drug review period has declined. However, debate continues whether PDUFA is directly associated with the acceleration in NDA review times, and whether the decrease in average NDA review time has compromised post-approval safety. Prompt: In a letter to the FDA Commissioner, describe the reasons you believe PDUFA should be amended, kept the same, or ended. Provide evidence to support your argument. Consider average drug approval times in recent years, post-approval safety problems, and the amount of user fees collected by FDA. Several websites you may find useful include:

Critique of a SpeakerFor this assignment, you are going to evaluate the verbal and nonverbal aspects of a speaker's presentation. An evaluation form is provided below to help guide your assessment of the content (what is being said) and the delivery (how it is said).Download: Module 03 Speaker Critique Form You have the option to go out and observe a live event, or you can watch one of the speeches from the Library Video Options provided below. The link will take you to a collection of student speeches. The recordings are classified as informative or persuasive; you are free to choose either type.Library Video Options: Student Speeches for Analysis SeriesDo the following, to complete this assignment:Print out the Speaker Critique Form (linked above), and familiarize yourself with the elements of the presentation that you will be assessing.View a presentation, a lecture, a sermon, or some sort of public speaking event. A live event would be great, but one of the Library Video Options (linked above) is acceptable.During the presentation, complete the Speaker Critique Form; consider including notes to help you remember specific details later.Write a 2-page paper, using proper spelling and grammar, that addresses the following:Provide an introduction describing who spoke, what they spoke about, and where you heard the presentation. If you chose to use a library video, be sure to clearly identify its title and provide a link to the specific video within the series.After the introduction, talk about what parts of the content were done well and what the speaker could have done better. Address at least 2 different elements of content.Next, talk about what parts of the delivery were done well and what the speaker could have done better. Address at least 2 different elements of delivery.End with a conclusive paragraph, giving your opinion about whether the speaker was effective or not. Explain your reasoning.

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