Review - 2937 Words

Order Code RS22814 February 21, 2008 FDA Fast Track and Priority Review Programs Susan Thaul Specialist in Drug Safety and Effectiveness Domestic Social Policy Division Summary By statutory requirements and by regulation, guidance, and practice, the Food and Drug Administration (FDA) works with several overlapping yet distinct programs to get to market quickly new drug and biological products that address unmet needs. FDA most frequently uses three mechanisms for that purpose: Accelerated Approval, Fast Track, and Priority Review. The first two affect the development process before a sponsor submits a marketing application. Accelerated Approval allows surrogate endpoints in trials to demonstrate effectiveness and is†¦show more content†¦105-115) directed the Secretary to create a mechanism whereby FDA could designate as â€Å"Fast Track† certain products that met two criteria. First, the product must concern a serious or life-threatening condition; second, it has to have the potential to address an unmet medical need. Once FDA grants a Fast Track designation, it encourages the manufacturer to meet with the agency to discuss development plans and strategies before the formal submission of an NDA/BLA. The early interaction can help clarify elements of clinical study design and presentation whose absence at NDA/BLA submission could delay approval decisions. However, FDA makes similar interactions available to any sponsor who seeks FDA consultation throughout the stages of drug development. A unique option within Fast Track is the opportunity to submit sections of an NDA/BLA to FDA as they are ready, rather than the standard requirement to submit a complete application at one time.4 2 Other options fit very limited situations and support shorter times from idea to approved public use. The Animal Efficacy Rule (21 CFR 314 Subpart I and 21 CFR 601 Subpart H) allows submission of data from animal studies of effectiveness as evidence to support applications of certain new products â€Å"when adequate and well-controlled clinical studies in humans cannot be ethically conducted and field efficacy studies are not feasible.† The ProjectShow MoreRelatedBook Review : A Review Of A Book Review1431 Words   |  6 Pages Book reviews are just that: a review of a book. They can be used for news articles, blogs, or academic journals. A book review is more than just a book report. It can give the reader more of an insight into not just the book, but the author as well. Most authors write of what they know. For example, some authors have backgrounds in law enforcement so they write about cases they know or have worked. Other authors research groups of people, for example the Knights Templar, and write of whatRead MorePeer Review825 Words   |  4 PagesENGL112 Peer Review Worksheet INSTRUCTIONS: Peer Reviews will be conducted in class discussion forums during Week 7. Be sure to review the Lecture and the Discussion area for additional details and guidance. Please complete the following steps below, returning a separate peer review worksheet for each of the two classmates whose papers you review. This assignment is worth 50 points. * You will receive 10 points for submitting your draft by the required deadline. * You will receive 20 pointsRead MoreTypes Of Peer Review : Review1158 Words   |  5 PagesTypes of peer review There are different journals which follow different types of peer review, based on the kind of research they publish as well as their journal management style. The single and double-blinded peer reviews are the most commonly adopted by many journals. In the single-blind review, the reviewer is aware of the author’s identity, but not vice versa. In the double-blind review, both the author and reviewer are not aware of the other’s identity. In the recent time, some academic journalsRead MoreTried And Tested:. The Impact Of Online Hotel Reviews On1028 Words   |  5 PagesTried and tested: The impact of online hotel reviews on consumer consideration Presented by Jinyue Wang 1000042488 Catalogue Introduction Literature review Methodology Findings Managerial Implication Supported Example 1 Introduction  · Research Gap Impacts of online reviews Researches on electronic word-of-mouth Relationships between users and contributors of review sites  · Research aim Find out the impact of online reviews to hotels’ potential consumers. i.e., their purchase decisions  · ResearchRead MoreJudicial Review2674 Words   |  11 PagesIntroduction The controversy of judicial review which at extreme points, is called judicial activism, is a concept new to India. Judicial review can be defined as the judiciary, in the exercise of its own independence, checking and cross checking the working of the other organs of the government, while trying to uphold the ideal of ‘the rule of law’. Judicial activism more reformist in character is often confused with judicial review. According to Black’s Law Dictionary, judicial activismRead MoreEmployee Performance Reviews Essay1296 Words   |  6 PagesPerformance reviews are designed to both evaluate general performance and measure progress around specific goals. Both negative and positive aspects are incorporated in these reviews as they should serve as a point of reference to both look back in evaluation and ahead in anticipation. Pulling back from daily demands in order to assess and review employee performance allows managers to focus their attention on specific departments and clarify what is high priority to their company. Performance reviews alsoRead MoreOnline Teen Forum Review Essay670 Words   |  3 Pagesindividuals, presumably teens, asking for book recommendations. Other users or staff members of the site give their opinion on what book would best fit the request that the user has made. Occasionally a user will offer their opinion in the form of a book review, although it is informal and still often takes the form of a recommendation. Perhaps the best example is a post from November of last year concerning The Faults in Our Stars. In the post, the author comments on how much she enjoys the writing ofRead MoreCRITICAL APPRAISAL OF A SYSTEMATIC REVIEW AND NARRATIVE REVIEW3844 Words   |  13 Pagesï » ¿CRITICAL APPRAISAL OF A SYSTEMATIC REVIEW AND NARRATIVE REVIEW RELATED TO COMPUTERISED PHYSICIAN ORDER ENTRY SYSTEM The author of this paper is a nurse educator working in an Intensive Care Unit (ICU) within the north-west region of England. For the purpose of this paper, the author has chosen a systematic review (SR) and a narrative review (NR) and aims to critically analyse these reviews using the Critical Appraisal Skills Programme (CASP) tool. The CASP tool has been developed by the SolutionsRead MoreWhat Is Peer Review?960 Words   |  4 PagesThe literature review What is peer review? Peer review is the evaluation of scholarly and academic articles by other researchers or scientists who are expert in the field and qualified enough to perform a reasonably neutral review. It is an indispensable part of the process of the scholarly publication. Most academic journals rely on scholarly peer review, or refereeing, to help editors evaluate the quality of articles submitted to their journals. The review process is a skill, which is learnedRead MoreEssay Literature Review1001 Words   |  5 PagesLiterature Review The purpose of this research project is for you to create a scholarly piece of graduate-level research and writing, which conforms to APA format. Competency in the APA format is required of all Business graduates of Liberty University, as set forth by policy of both the Graduate Faculty and the administration. You will research and write a literature review on a topic relevant to our course. What is a Literature Review? â€Å"A literature review discusses published information