...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 relevant in fewer situations than the others. The Fast Track program encourages a sponsor to consult with FDA while developing a product. Unlike the others, Priority Review involves no discussions of study design or procedure; it relates only to an application’s place in the review queue. Analysis of total approval time for approved applications under the Fast Track and Priority Review programs shows that for seven of the past nine years, Fast Track products have shorter median approval times than do all those applications assigned to Priority Review. It takes an average of 15 years from the moment a manufacturer first approaches the Food and Drug Administration (FDA) with an idea for a new drug to its final approval for marketing.1 Steps...
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...wanted to marry Teang and asked for his dad’s permission. Even thought Dodong thinked twice of marrying Teang, they still got married. After nine months, Teang gave birth to their eldest son Blas. Teang really regretted getting married in an early age. Her husband doesn’t know about this. She even wondered if ever she got married to Lucio who was nine years older than Dodong. When their son, Blas turned 18, he told his father, Dodong that he would marry Tona. Dodong didn’t rejected or complain he just talk to his son that he should not be rushing to marriage and Dodong doesn’t want his son to experience and be like him at the end. BODY AND CONTENT Dodong is the main character. Teang is the wife of Dodong who regretted marrying at an early age. Lucio is Teang’s other suitor who got married after she did and who is childless now. Blas is Dodong and Teang’s eldest son who followed their footsteps in the end. Blas also contemplated to marry Tona at the age of 18. Tona is the woman whom Blass wants to marry. EXERCISE 1. Who is the protagonist in the story? 2. What is the climax in the story? 3. Does Teang really wanted to get married in an early age? 4. What kind of character does Blas portray? 5. How old did Dodong got married? 6. Who is the other suitor of Teang? 7. How old did Blas got married? 8. Who is the eldest son of Dodong and Teang? 9. What is the falling action in the story? 10. Is the narratos reliable or unreliable?...
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...footsteps of his parents. He wants to marry also at the age of 17. He told his parents what his plans. Dodong have nothing to do but explain how hard and how risky to be in "marriage "at the young age.. But like dodong before, his son also wants to pursue what he wants. The lesson we can learn is that marriage can wait the right time, if we want to be in this stage of life, we must prepare ourselves against the risk of it. I know we can all be in to it if we like too but not at the young age. This would be a lesson for youth like me. Jose Garcia villa is a great write coz aside from having nice story; he also had the point of view where we can have the knowledge of something related to what will happen to us. Major characters: 1. Dodong- main character of the story who got married at the age of 17 2.Teang - regretted marrying at an early age 3. Lucio - Teang's other suitor who got married after she did and who's childless until now. Minor Characters 4. Blas - Dodong and Teang's oldest son who followed their footsteps in the end. Blas contemplated to marry Tona when he was 18 5. Tona - woman whom Blas...
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...Notably, a new genetic study shows even siblings with autism often have very different DNA mutations from one another further implying the heterogeneity of ASD14. Although, the genetic basis is well documented, a large upsurge in clinical cases of idiopathic Autism in recent past directs us to the fact that environmental risk factors might have an important contribution to this upsurge either by causing new mutation or increasing the risk in a genetically predisposed individual 15-17. One such animal model is Valproic acid model of Autism 18-20. This model is based on the discovery that when the anticonvulsant drug, VPA, is administered to women during their first trimester of...
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...consent. Nine months later, Dudong is waiting outside while Teang gives birth to their first son, Blas. He feels young and inexperienced, a contrast to how he felt nine months ago. Dudong did not want any more children, but they came anyway. For the next six years, Teang gave birth. Seven children in all. Teang did not complain. However her body was now shapeless and thin from bearing so many children and from the hard work of caring for them and the household. Even though she loved Dudong, she cried and wished that she had not married so young. There had been another suitor, Lucio, who was nine years older than Dudong. She chose Dudong because he was so much younger. Lucio had married after she married Dudong, however, he was childless. She wonders if she had married Lucio, would she be childless? She feels that would have been a better lot in life. But she loves Dudong, even though life has made him old and ugly. One night Dudong goes outside and thinks about his life. He wants to have the wisdom to know why life does not fulfill Youth's dreams. Why did life forsake you after love? He never finds the answer. When Blas turns 18, he comes home and tells Dudong that he wants to marry Tena. Dudong at this time is only 36 years old, but he is portrayed as a much older man. Dudong does not want Blas to marry so young. He asks the same question his father asked him. Does Blas...
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...i should thank God for everything.. for giving me another life,, FULL OF HOPE, COURAGE and PATIENCE.... despite of my ALONENESS, AMBIGUOUS, INDISTINCT and OBSCURE!..... i thank God for my friends, cousins and reLatives whose willing to Listen and be a part of my well-being.... THANK YOU FOR EVERYTHING....... upon reading aLL comments, stories bla bla bla,,, i came to the pOINT dat i ANNOYed soMeboDy's feeLing... i might affect somebOdy's Life and dat's soo much meant to me.. im sOrry... fOr being Like this.. Im soRRy,, for wanting me To ChANGE... LIFE IS A CYCLE, RIGHT?? but have to move in a sLow process........ im bad im weak im wicked im atrocious im irresponsible im careless im rebellious THAT'S ME... and dat's wat other peOpLe see within On me... JUDGEMENTAL... people always see me for being Like that... aLways negative and there is NO GOOD DEEDS.. IM ONLY HUMAN... IM IMPERFECTLY NOT PERFECT.. at this pOint of time..... i cant hOld up my tears to faLL.... every singLe Letter i made,, was a biG heLp for me coz it graduaLLy Lessen the pain... Now if Your concern,, just understand for WHO I AM for WHAT WILL I BE... everything happens for a reason,,,.. THANK YOU FACEBOOK!! >>coz i FEEL FREE to burst Out and SHOUT out my PAIN AND ANGUISH! >>for being there wen i feeL isoLated and deserted... NOBODY know's what i reaLLy feeL right now... BEFORE, DURING AND AFTER.......
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...Types of Brain Imaging Techniques By MICHAEL DEMITRI, M.D. Brain imaging techniques allow doctors and researchers to view activity or problems within the human brain, without invasive neurosurgery. There are a number of accepted, safe imaging techniques in use today in research facilities and hospitals throughout the world. fMRI Functional magnetic resonance imaging, or fMRI, is a technique for measuring brain activity. It works by detecting the changes in blood oxygenation and flow that occur in response to neural activity – when a brain area is more active it consumes more oxygen and to meet this increased demand blood flow increases to the active area. fMRI can be used to produce activation maps showing which parts of the brain are involved in a particular mental process. CT Computed tomography (CT) scanning builds up a picture of the brain based on the differential absorption of X-rays. During a CT scan the subject lies on a table that slides in and out of a hollow, cylindrical apparatus. An x-ray source rides on a ring around the inside of the tube, with its beam aimed at the subjects head. After passing through the head, the beam is sampled by one of the many detectors that line the machine’s circumference. Images made using x-rays depend on the absorption of the beam by the tissue it passes through. Bone and hard tissue absorb x-rays well, air and water absorb very little and soft tissue is somewhere in between. Thus, CT scans reveal the gross features of the...
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...Shawn Wiley CRJ 419 American Terrorism Charles Loftus Assignment 4 Part Two June 16, 2013 More Domestic Terrorist Than the Public Realizes With only a few mentioned in part one of this two part essay, there are actually many more domestic terrorist groups that are coming to light. Domestic terrorism has been around for many years and probably for many more. There are going to be groups or even individuals that will have their own beliefs and may even try to push those beliefs onto others. So because of this domestic terrorism is going to be around for a long time. Looking through history I have found a few domestic groups that weren’t mentioned in part ones essay but I feel should be addressed. Ku Klux Klan can never be ignored as one of the most prominent of all domestic terrorist groups in the United States. Another one is Phineas Priesthood, and lastly a group Americans must focus on is Black Liberation Army. These are the three that I think should really be focused on, for they seem to be mentioned by the F.B.I. in a lot of Domestic Terrorism articles. Ku Klux Klan (KKK), just the name sounds of something bad is about to happen. The Klan has been causing havoc since 1865. Is definitely one of the oldest and most infamous for violence than any other domestic group on American. Most believe that blacks are the main subject of the Klan, but that isn’t necessary true anymore. They tend to focus on attacking Jews, immigrants, gays, and lesbians...
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...Saudi Wells Running Dry — of Water — Spell End of Desert Wheat Saudi Arabia, at one point, grew so much grain that they could fee Kuwait, United Arab Emirates, Quatar, Bahrain, Oman and Yeman (Blas, Javier; Saudi Wells Running Dry — of Water — Spell End of Desert Wheat). Unfortunately, that is no longer the case. The lack of rain and essentially hot weather, has caused the water to run dry, in turn causing their wheat crops to die. Saudi Arabia’s inability to produce wheat, has caused them to look elsewhere for their own supply, looking for imports and naming the Saudi’s "The largest new wheat buyer to emerge," (Blas, Javier; Saudi Wells Running Dry — of Water — Spell End of Desert Wheat). According to Ahmed bin Abdulaziz Al-Fares, managing director of the Grain Silos and Flour Mills Organization (GSFMO), all wheat farmers are to be phased out leading to 3.5 million metric tons, which is 100% of Saudi Arabia’s wheat for the year 2016, to come from imports. How does Saudi Arabia’s lack of water and inability to grow wheat effect the global economy? Some farmers have lobbied the government to overturn their decision to cease farming, stating that they have loans to pay back and without the ability to grow and sell their crops, they will not be able to pay them back leading to financial hardship. While there is an economic downfall to those in Saudi Arabia, at the same time, there is a boost to other parts of the world. Saudi Arabia is now importing their wheat and buying...
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...KIND OF RECIPES, EASY? CHEAP? 3. WHY DO YOU BELIEVE THIS PRODUCT/SERVICE HAS AN ADVANTAGE in the marketplace relative to the market/consumer needs? --> convenient, easy to use, simple, accessible,cheap, .... Anything! 4. Evidence and reference to testimonials or CUSTOMER FEEDBACK? --> Use the results of your survey and show that people are very interested! 5. What’s the COMPETITION in the marketplace (brief appraisal of current market, product, and service offerings with a view to justify market possibilities)? 66> THE COOK BOOK paper one and online one, but you can say that most young people think that paper cook book seems old-fashion and rather prefer to check on the internet or phone, but it is more suitable to have your phone with you in the kitchen or if you suddenly decide to prepare something at someone else place rather than take your laptop with you n the kitchen 6. Who’s the TEAM that's going to make the business succeed? (drawing upon strengths of team; good distribution of work load, presentation time) --> what are the strenghts in your team? are you good in marketing, It, finance?? what distribution network/ channels are you gonna use to promote your product? 7. How would you realise the business opportunity in the first year (steps, stages, critical transition points)? 8. What’s the TOTAL FUNDING required to get the business opportunity launched in THE FIRST YEAR and what would this funding be spent on? 9. What’s the longer term vision...
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...Base Line Intro Job satisfaction enhancement programs are widely researched and implemented in business of all sizes today. Job satisfaction has direct correlations to both performance and retention in the workplace resulting in a need for employees to seek ways to improve employee satisfaction. There exists many factors that affect employee satisfaction including working conditions, opportunity for advancement, stress level, respect from co-workers, and relationships with supervisors however implementing these factors can prove challenging. While creating a respectful work environment is expected in most professions programs to enhance or establish are difficult to baseline. In contrast there exist several established methods and programs designed to enhance employee satisfaction that are widely used in business. Programs such as increased promotions, flexible work schedules, mentoring programs, formal recognition and rewards, training and skills training, and other low-no cost programs exist. These programs typically have a cost associated with both establishment and maintaining the program however in many cases the benefits far outweigh these costs. In addition to these higher cost programs low-no cost programs exist such as allowing customized work areas, relaxing the dress code, open door policies, contests, and even the occasional free lunch. Increasing promotions Increasing promotions would be a direct response to an employee’s dissatisfaction with pay, opportunity...
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...Afzal Hasan Uddin Development of this Guideline is sponsored by IFC-SEDF, H&M, Carrefour, Levi Strauss, Lindex, Tesco International Sourcing, Disney Corporation and JC Penny Prepared by Reed Consulting Bangladesh Ltd. www.reedconsultingbd.com Date of Submission: December 31 2011 Guideline for Participation Committee (PC) Development and Standardisation Chapter 1 2 3 4 5 6 7 Table of Contents The purpose of the Participation Committee Membership of the Participation Committee The Office-holders of the Participation Committee The places for Management Representatives The places for Workers’ Representatives The powers of the Participation Committee compared to those of a Trades Union or in an EPZ a Workers’ Welfare Association Preparation for the formation of a Participation Committee or in preparation for new Representatives joining the Participation Committee 8 9 10 11 12 13 14 15 16 17 The duration of the Participation Committee Member Secretary of the Participation Committee Standard Documents Participation Committee Standard Procedures Election Procedure Role Description Participation Committee Member An implementation programme for the formation or development of a Participation Committee Grievance Procedure Company Suggestion Box – ‘3C Boxes’ (Comments, Complaints, Compliments) Flowchart of Participation Committee Function 28 23 26 8 9 10 13 14 16 17 8 Page 3 3 4 5 5 6 2 Participation Committee Guideline The purpose of this Participation Committee Guideline...
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...In my Behavioral Neuroscience class, Dr. Miller told us a story about a 70-year-old veteran who was on his way to the post office to send a letter to his son. As he got out of the car, his gaze fell upon the tall, slender pole that had raised the American flag proud and high. However, for this gentleman, he, unfortunately, had an adverse reaction as he stared at the flag. His heartbeat was on a full rush, his hands became sweaty, and it became suddenly hard for him to keep standing. At that moment, he was taken back to his war years and relived the moment when his partner, who’d been carrying the American flag, was killed right before his eyes. The poor old man became terrified that he would face the same fate as his friend, even though the...
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...before it came to be Used refer to a genre of music it meant “fiesta del patio” (party in the backyard) All friends, family get together to eat to have a good time. They drink and play guitar Music peacefully, but lets not forget the most important parts dancing. It was in the 1961 that bachata came to life with the voice of Jose Manuel Calderon He is call the “father of Bachata” butwhen Blas Duran came to along he simplified The music, making it easier for dancers and added electric guitar to this song “Consejos a las mujeres” and he became a huge hit, paving the road to bachata’s Acceptance by much wider segment of the population. Later Juan Luis Guerra A Dominican born, Berkley educated musician made bachata widely know and Accepted with his album “ Bachata Rosa”. Juan Luis Guerra is a master of music Although he is not regarded among bachata musicians as a true bachatero, he Did however play an important part in internationalizing the word and music Because of his wide appeal and great songs and lyrics, others such as Blas Duran, Monchy Alexandra, Anthony Santos, extreme and Aventura played a huge Roles in introducing the music to the words. By the 1990 bachata turn to romance With Anthony Santos, Luis Vargas and raulin Rodriguez they focused bachata’s Themes to the romantic so...
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...Dodong pitied her and want to have a sister who can help her. * Dodong’s Father – A silent and hardworking farmer. Dodong think that he would be refused by him. * Blas – Son of Dodong Also wanted to get married, by his age of 17 * Lucio – A suitor of Teang. Nine years older than Dodong. * Tona – woman whom Blas wants to marry Setting: The primary action takes place on their farm land especiallyon the field where the crops are planted wherein the ground is broken upinto many fresh wounds and fragrant with a sweetish early smell. It hasmany slender soft worms emerged from the furrows and then burrowedagain deeper in the soil. The time setting is almost the whole day from the morninguntil evening. The period of history on this story is on the 20th-21stcentury. It is the time of planting season almost June to August. There isno specific time of the day because it happens almost the whole day. Conflict/Problem: Internal conflict confronts the leading character. Internalcharacter in a way that he was struggling if he can managed himself tohave a family because he knows that he is in the legal age that he can beindependent and can definitely choose the right from wrong. But becauseof his foolishness, he had difficult time meeting the expectations that hemust achieve. Theme: The general theme for this story is youth must triumph now.Love must triumph now. As long ago did youth and love triumph for Dodong and then life. That life is not as easy as it should be. Life...
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