the food and drug administration assigns newly approved drugs to which categories? (select all that apply.)
Answers
The food and drug administration assigns newly approved drugs to categories that indicate the drug's usage, potential benefits and risks. These categories include Prescription Drug User Fee Act (PDUFA), Orphan Drug Act, Accelerated Approval Program, and Fast Track Designation.
The Food and Drug Administration (FDA) assigns newly approved drugs to categories that indicate the drug's usage, potential benefits and risks. The categories include: Prescription Drug User Fee Act (PDUFA), Orphan Drug Act, Accelerated Approval Program, and Fast Track Designation.
Prescription Drug User Fee Act (PDUFA):The Prescription Drug User Fee Act is a program that requires drug manufacturers to pay a fee when submitting a new drug application (NDA) to the FDA. In return, the FDA agrees to meet certain performance goals for the review of the NDA.
Orphan Drug Act:The Orphan Drug Act provides incentives to drug companies to develop and market drugs for rare diseases. The act provides tax credits, grants, and marketing exclusivity to companies that develop drugs for rare diseases.
Accelerated Approval Program:The Accelerated Approval Program is a program that allows drugs for serious conditions that fill an unmet medical need to be approved on the basis of a surrogate endpoint. A surrogate endpoint is a marker that is used to predict clinical benefit.
Fast Track Designation:Fast Track Designation is a program that expedites the development and review of drugs for serious conditions that fill an unmet medical need. The program provides companies with more frequent meetings with the FDA, the option of submitting parts of the NDA on a rolling basis, and the possibility of accelerated approval based on surrogate endpoints.
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Related Questions
Explain at least two ways that you might know if someone was in
the early stage of alcoholism verses the late stage of alcoholism
Answers
Answer:
I can only think of one, sorry.
Say that there are two people- person A and person B.
Person A is in the early stage of alcoholism and person B is in the late stages of alcoholism. Both are not light weights. Give both of them the same number of beers, and see their reactions after finishing it. Person A will definitely be more drunk than person B. So, I guess, one way to tell that a person was in the early stages of alcoholism would be that they can't handle liquor that well compared to someone in the late stages of alcoholism.
Explanation:
It's kinda like the saying "practice makes perfect." The more beers you drink, the more liquor you can handle.
Explanation:
The Diagnostic and Statistical Manual of Mental Disorder-5 (DSM-5), a publication of the American Psychiatric Association, provides professionals in the mental health field with an indispensable diagnostic tool that helps them to identify the various mental health disorders, including alcohol use disorder.What Is End-Stage Alcoholism?
End-stage alcoholism, or late-stage alcoholism, is the final stage of an alcohol use disorder, resulting in serious physical and mental conditions as well as other life consequences from years of alcohol misuse.
What are lactate levels
Answers
Answer:
The lactate blood test is primarily ordered to help determine if someone has lactic acidosis, a level of lactate that is high enough to disrupt a person's acid-base (pH) balance. Lactic acidosis is most commonly caused by an inadequate amount of oxygen in cells and tissues.
Explanation:
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Which of the following statements is true of mobile
medical facilities?
1. They are often housed in vans or buses.
2. They are a type of hospice facility.
3. They contain a lot of exercise equipment.
4. They offer long-term care.
Answers
Answer:
1. They are often housed in vans or buses.
Explanation:
"Mobile medical facilities" are meant to provide care to people who are far from the hospitals or have a hard time receiving medical care due to their locations and situations. It is also meant to reach out to those who often have no means of seeking medical treatments such as the underprivilege communities.
These facilities are housed in vans or buses. They are not a hospice facility because they don't focus on terminally-ill patients. It also means, they don't provide a long-term care because these vans or buses travel from one destination to another and don't stay in the area for long time.
Carla is drawing a picture of the cardiovascular system to share during her class
presentation. What would MOST likely be included in her drawing as a feature of this
system?
a-the bones
b-the lungs
c-the heart
d- the skeletal muscles
Answers
Answer:
c
Explanation:its c
explain the concept of biodiversity.
Answers
Answer:
Biodiversity is defined as “the variability among living organisms from all sources including, inter alia, terrestrial, marine and other aquatic ecosystems and the ecological complexes of which they are part; this includes diversity within species, between species and of ecosystems.” The importance of this definition ...Biodiversity is usually explored at three levels - genetic diversity, species diversity and ecosystem diversity. These three levels work together to create the complexity of life on Earth.The word biodiversity is a contraction of the phrase "biological diversity" and was first coined in 1985 by Walter Rosen of the National Research Council as a title word in a seminar he was organizing to discuss biological diversity.
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Based on which of the following signs and symptoms would you determine that a victim is experiencing respiratory distress?.
Answers
Answer:
You determine that there is no breathing or pulse and state, "Victim has no pulse or being short of breath
Explanation:
are
ghost kitchens formal or informal? (structure)
Answers
Ghost kitchens can be both formal and informal in terms of their structure, as they can operate in various ways depending on the specific business model and legal framework.
Ghost kitchens, also known as virtual kitchens, cloud kitchens, or delivery-only restaurants, are commercial food preparation facilities that solely focus on the production of food for delivery or takeaway.The structure of ghost kitchens can vary depending on how they are organized and operated.Formal ghost kitchens often operate within a legally recognized framework. They may be established as separate legal entities, such as LLCs or corporations, with proper licensing, permits, and compliance with health and safety regulations.Formal ghost kitchens may have a dedicated physical space or operate within existing commercial kitchens or restaurant facilities.They may have a centralized management structure with specific roles and responsibilities for employees, including chefs, kitchen staff, and delivery personnel.Formal ghost kitchens typically have a well-defined business plan, financial management systems, and marketing strategies in place.On the other hand, informal ghost kitchens may operate in a more flexible and less regulated manner.Informal ghost kitchens can include home-based operations or temporary pop-up kitchens that operate without the same level of formal structure or legal recognition.These informal ghost kitchens may not have the same licensing or permits as traditional restaurants, and they might rely on online platforms and social media for marketing and order placement.Informal ghost kitchens often have a smaller scale of operation and may not require a dedicated physical space or a large team of employees.It is important to note that the distinction between formal and informal ghost kitchens may vary depending on local regulations and legal requirements in different jurisdictions.Ultimately, the formality or informality of a ghost kitchen's structure depends on the specific business model, legal considerations, and operational practices adopted by the kitchen.For more such questions on structure, click on:
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Which statement is true regarding vascular access devices (VADs)?
1. The word "central" applies to the insertion site.
2. Central catheters are long-term devices.
3. Peripheral catheters are used for long-term antibiotic administration.
4. Peripheral catheters are more effective for administration of large volumes of fluids.
Answers
The true statement regarding vascular access devices (VADs) is that central catheters are long-term devices (option 2).
What are vascular access devices (VADs)?
Vascular Access Devices (VADs) are tubing that is inserted into a vein, artery, or under the skin. These devices aid in the administration of fluids, blood products, medications, chemotherapy, and blood sampling. VADs are also used to provide permanent access for hemodialysis.
What are central catheters?
Central catheters are long-term devices that are inserted into a large vein, such as the superior vena cava or inferior vena cava. This is why the term "central" refers to the insertion site. Central catheters are used for chemotherapy, total parenteral nutrition, hemodialysis, and other treatments that require long-term or frequent access to the bloodstream.
Therefore, the correct answer is: The true statement regarding vascular access devices (VADs) is that central catheters are long-term devices.
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how many teenagers were killed in alcohol related crashes in VA in 2018
Answers
Answer:
70
Explanation: In teen-driver related fatalities, 70 people in Virginia died in 2018 — a 22% rise from the previous year.
1. What source of nutrition does poultry provide in human diet? 2. What do you mean by the deboning of poutlry? 3. When presenting a poultry preparation what are the additional three components on the plate? 4. Which wine would you recommend to your guest to accompany a chicken dish? 5. Breast of chicken is referred to as of chicken in French Culinary. 6. Which part of chicken is referred to as white meat and which is referred to as dark meat? 7. What are the different methods of cooking used in preparing chicken (name any three)?
Answers
Answer
1 protein
2 To break it down
3 colour
canvas
slicing
4 Sauvignon Blanc
5 Frenched chicken breast
6 Breast
7 Stir-frying
Pan-frying
Grilling/BBQ
Explanation:
Poultry is a source of mostly protein intake and it is used for the maintenance of protein.
1) Poultry provides a rich source of nutrition in the human diet. It is a good source of high-quality protein, which is essential for building and repairing tissues in the body.2) Deboning of poultry refers to the process of removing the bones from the meat of poultry. It involves carefully separating the bones from the flesh, ensuring that the meat remains intact.
3) When presenting a poultry preparation, the additional three components on the plate can vary depending on the specific dish and culinary preferences. However, common components often include Accompaniments or side dishes, Sauces or gravies, Garnishes.4) When recommending a wine to accompany a chicken dish, it is important to consider the flavors and cooking method of the dish.
5) Breast of chicken is referred to as "blanc de poulet" in French culinary.6) In terms of chicken, the breast meat is considered white meat, while the leg and thigh meat is considered dark meat.7) There are several methods of cooking used in preparing chicken. Here are three common methods Roasting, Grilling, Frying.
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What way can you overcome something that affected you in the past and stills affects you today?
Answers
Answer: If you ever have these feelings again, think that they are in the past and can't hurt you anymore, and be glad that it's over. No one knows your situation so it is hard to give a definite answer, but it is good to do things that keep your mind distracted for the greater good.
Explanation:
HELP!!!!! Which strategy combines defensive and offensive tactics in water polo?
Staying in the correct lane or station in the pool avoids penalties and injuries in water polo.
Swimming defensively toward the inside lane is an offensive strategy in water polo.
Scoring offensively with both hands on the ball is an allowable strategy in water polo.
Using proper body mechanics is important when playing different positions in water polo.
Answers
Answer:
The second one
Explanation:
In water polo, staying in the correct lane or station in the pool prevents penalties and injuries. The correct option is A.
What is water polo?Water polo is a water-based team game in which two squads of seven players each.
The game is divided into four quarters, with each team attempting to score goals by flinging the ball towards the opposing team's goal. The match is won by the team with the most goals at the end of the game.
It is widely regarded as the world's most difficult sport to master, requiring a rare combination of stamina, strength, aerobic fitness.
Also the determination to win numerous dozen wrestling matches per game against frighteningly strong opponents. Because the playing pool is two meters deep, no sneaky walking is permitted.
Staying in the right position or station in the pool prevents penalty points and concussions in water polo.
Thus, the correct option is A.
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what happens to your thrz over time if you have a regular workout program?
Answers
If you have a regular workout program, your resting heart rate (RHR) or THRZ (Target Heart Rate Zone) may decrease over time. Regular exercise can improve your cardiovascular health,
leading to an increase in the efficiency of your heart and a decrease in your RHR. This is because exercise strengthens the heart muscle, allowing it to pump more blood with each beat, which means it does not have to work as hard to circulate blood throughout the body at rest.
As you become fitter, you may also find that you are able to exercise at a higher intensity while still remaining within your THRZ. This is because regular exercise can increase the strength and efficiency of your heart and lungs, allowing them to deliver more oxygen to your muscles during exercise. This means that your body can work harder without your heart rate increasing as much, which means your THRZ can become lower as you become more fit.
It is important to note that the specific changes to your THRZ over time will depend on various factors, including your age, genetics, current fitness level, and the type, frequency, and intensity of your exercise program.
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What is the purpose of the maintenance phase of recovery?
A. to reduce the life-threatening effect of alcohol withdrawal
B. to help the recovering alcoholic avoid relapse
C.to help the patient choose a treatment that best suits his or her needs
D. to exp ain the dangers nvolved in continued alcoho abuse
Answers
The purpose of the maintenance phase of recovery is B. to help the recovering alcoholic avoid relapse
What is the purpose of the maintenance phase of recovery?The maintenance phase of recovery can be regarded as the stage whereby the individual that found themseves in the case will be working hard so as to make the prvention of the addiction recovery relapse.
It should be noted that the are keeping up the lifestyle changes they have now which could be varies such as getting regular exercise as well as recreational activities and they will want to survive the legacy that they just made.
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Trevor has been diagnosed with heat exhaustion after his track meet. What is the MOST logical action he should take in response to this diagnosis?
A. He should call 911.
B. He should take a warm bath.
C. He should go for a short walk.
D. He should elevate his legs.
Answers
List symptoms of mild allergic reaction
Answers
Answer:
Buttons on your skin
Throwing up
Rash
Pain in body
Explanation:
You didn't give a passage or anything so yeah I just had to use my brain .-.
Answer:
hives (itchy red spots on the skin)
itching.
nasal congestion (known as rhinitis)
rash.
scratchy throat.
watery or itchy eyes.
Explanation:
c) What is homeostasis? (1 point)
Answers
Answer:
an organism tends to maintain stability while adjusting to conditions that are best for its survival.
Explanation:
Which sport requires participants to wear safety equipment during competition?
Swimming
Badminton
Basketball
Hockey
Answers
Explanation: In hockey you have to wear a bunch of padding, to make sure you don’t super injured and in the other sports that are listed you don’t have to
Why is it important to learn about puberty when talking about menstruation, childbirth & pregnancy?
Answers
Answer:
because puberty flourishes all of the things
Explanation:
ex: once you hit puberty you get your period once you get your period can get pregnant
What is most important for a person to look for in hot weather exercise clothing ?
Answers
who invented badminton ?
Answers
Answer:
Invented in India in a version called poona. British army officers learned the game about 1870. In 1873 the duke of Beaufort introduced the sport at his country estate, Badminton, from which the game derives its name.
Explanation: You're welcome :) maybe mark brainlist....
Answer:
A person :)
Explanation:
i need help for this question it is for health. pleasee!
Answers
Answer: A, C , E, G, I,
Explanation:
What is a function of the organ labeled R? SC. 6. L. 14. 5Immersive Reader
(5 Points)
to absord excess water
to digest food and absorb nutrients
to physically break down food
to produce bile to break down food
Answers
Answer:
D to produce bile to break down food
Explanation:
_____ is a spot reducing procedure that involves inserting a thin tube into an incision that allows access to the fat tissue. The fat cells are then suctioned out through the tube and discarded.a. Botox injectionsb. Gastric plicationc. Liposuctiond. Cryolipolysis
Answers
Liposuction is a spot reducing procedure that involves inserting a thin tube into an incision to access the fat tissue.
Through this tube, fat cells are suctioned out and discarded. Liposuction is a surgical cosmetic procedure that aims to remove localized fat deposits from specific areas of the body, such as the abdomen, thighs, hips, or arms. It is not a method for overall weight loss but rather for contouring and shaping specific areas.
During liposuction, the surgeon typically injects a solution containing local anesthetics and vasoconstrictors into the target area. This helps minimize bleeding and swelling. Then, a small incision is made, and a thin tube called a cannula is inserted to break up and suction out the fat cells. The procedure may be performed under general anesthesia or with local anesthesia, depending on the extent of the surgery.
Liposuction has been a popular cosmetic procedure for many years, providing individuals with the opportunity to enhance their body shape and proportions. It is important to note that liposuction is not a substitute for a healthy lifestyle, including regular exercise and a balanced diet. It is crucial to consult with a qualified plastic surgeon to discuss the benefits, risks, and expectations associated with liposuction before undergoing the procedure.
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What two factors have contributed to the U.S. reaching its lowest teen pregnancy and birth rates in years.
Answers
If someone can write about a current event I will give you 100 points and mark Brainly take your time if you need to but plz help me
Answers
Answer:
Special events hve specific place in our heart .for me If my mother has laugh when i joke it is special for me because if somebody laugh it is nothing but my mother it is special.
Answer:
Answer:
y=-3x+5
-10x+8y=-8
x-y=5
3x-2y=-6
x+2y=4Explanation:
Which of these organs produces estrogen progesterone
Answers
Answer:
Ovaries make eggs and hormones like estrogen and progesterone
Explanation:
During the Trial stage of T.R.A.P, what type of damage occurs to the body?
Answers
Answer:
TRAP is known as an absence of the fetal heart organ in intrauterine life, but not in any situation.
But in that during the pregnancy of twins, that is why one of the embryos presents perfect cardiac pumping with the cardiac vital organ present, and another does not.
This affects the embryo or fetus that has the heart through which it has to send the blood supply through the venous artery to the twin that is developing together with it, at risk of life.
In simple words TRAP is the absence of the heart in one of the twins in intrauterine life.
Explanation:
In these cases, the twin who sends blood circulation through the venous artery to the neighboring twin without a heart pump is called a twin pump and in almost 50% of cases he dies of cardiac overload.
A man was in a car accident and fractured cervical vertebrae, his femur, and his fifth metatarsal. Explain his injuries to a “nonscience” person. *
Answers
Answer: This mas has fractured his back, leg, and middle foot.
Explanation: Back, leg and middle are the "nonscience" words for cervical verebrae, and the fifth metatarsal.
The nerves in the spinal cord can regenerate slowly
Answers
Answer:
Not sure if you’re looking for true or false but damage to the spinal cord really heals because the injured nerve cells field to regenerate. The regrowth of their long nerve fibers is hindered by scar tissues and molecules processes inside the nerve.
Explanation:
Answer:
B. False
Explanation:
See attached image.
