A pharma company is awaiting FDA approval for a new drug. It is their first and their only product. They have nothing else in the pipeline. Can you provide an approximate for the beta of the company during the FDA approval process.

Answers

Answer 1

Answer:

It would not be advisable to promote a product before they approve it since you do not know if they will validate it and you will spend on marketing for pleasure

Whether or not a new drug requires approval The FDA's dependence on the new drug fits an over-the-counter (OTC) monograph. OTC monographs specified conditions under which the FDA has predetermined that a medication will be safe and effective. Once an OTC monograph is finalized, medication devices can market OTC medications that conform to the monograph without FDA approval. The FDA also uses the application at its discretion to allow certain medications to be marketed without approval if they conform to tentative final monographs.

If a new medication does not meet a monograph, it will require FDA approval. To obtain FDA approval, drug manufacturers must conduct laboratory tests, animal and human clinical analyzes, and submit their information to FDA. The FDA will review the information and may then approve the medication if the agency determines the benefits of the medication plus the risks to the intended use. Marketing a new drug that is not compliant with an OTC monograph and without an FDA test is considered as marketing a new unapproved medication, which is a prohibited act under the Food, Drug and Cosmetic Act (FD&C Act).


Related Questions

A mother tells the school nurse that her 5-year-old is refusing to go to school and won’t accept a ""school night"" bedtime. The school nurse knows the mother will need more instruction when the mother makes which statement?

Answers

Answer:

"I don't know why he is acting like this. He hasn't had anyone to play with but his little brother all summer."

Explanation:

This child got used to playing all day, everyday, during summer with his little brother. He is young and he can't be explained how he must take his obligation seriously and that the summer time is over. He's going through stress and coping with the fact that he won't be able to play anytime he wanted, and he would need adaptation to the new-found obligations.

Jeremy was born with serious heart, face and finger deformities. He is also showing signs of delayed motor development and lowered intelligence. Jeremy is most likely suffering from____.
a) Fetal alcohol syndrome
b) Premature birth
c) Prenatal exposure to nicotine
d) DNA syndrome

Answers

Answer: a) Fetal alcohol syndrome

Explanation:

Fetal alcohol syndrome is a condition which can be seen in a child. This syndrome develops in a child due to exposure to alcohol in prenatal development. It causes damage to the brain and poses a problem in growth. It delays motor development and lowers the cognitive development responsible for lowering the intelligence level. These children will have thin upper lips, small eyes, and deformities of the fingers and face. This child will be born with a defective heart.

The extent of injury resulting from _____ is typically not immediately visible because the current flows through muscle tissue and organs and not through the skin, except at the entrance and exit points.

Answers

Answer:

The answer is Eletrical Shock

Explanation:

The extent of injury resulting from _Eletrical Shock____ is typically not immediately visible because the current flows through muscle tissue and organs and not through the skin, except at the entrance and exit points.

A 6-month-old child developed kernicterus immediately after birth. Which of the following tests should be done to determine whether or not this child has developed any sequelae to the illness?
A. Blood urea nitrogen and serum creatinine.
B. Alkaline phosphotase and bilirubin.
C. Hearing and vision assessments.
D. Peak expiratory flow and blood gas assessments.

Answers

Answer:

C. Hearing and vision assessments.

Explanation:

(Because the CNS may have been damaged by the high bilirubin levels, testing of the senses as well as motor and cognitive assessments are appropriate. Kernicterus is the syndrome that develops when a neonate is exposed to high levels of bilirubin over time. The bilirubin crosses the blood brain barrier, often leading to toxic changes in the CNS. The term sequelae refers to the disorders that result after an individual has experienced a disease or injury).

Drinking at least 6 liters of water daily a. is recommended by the National Academy of Sciences b. is necessary for healthy persons even if they are not thirsty c. can result in water intoxication d. improves athletic performance

Answers

Answer:

option C.

Explanation:

The correct answer is option C.

Drinking at least 6 Liters of water can help in the intoxication of the body.

When a person drinks a lot of water it mixes with the blood and dilutes the electrolyte basically sodium present in the water.

And the balance between sodium and water should be maintained.

If the sodium level decrease the water enters into the cell which leads to swelling of the cell.

When this happens it can produce dangerous and life-threatening effects.

A child's history of a recurrent sore throat followed by severe knee and ankle pain has resulted in a diagnostic workup and a diagnosis of rheumatic fever. What are the treatment priorities for this child?

Answers

Answer:

Treatment priorities would include running a test to check thyroid hormone levels. The child may also need to have an x-ray to evaluate the physicality of their knee symptoms and check their breathing and heart rate. I would be curious how long the child had these symptoms, and how it effects their emotional wellbeing.

Explanation:

Mary, who has a great fear of flying, has been instructed by her behavior therapist to take a brief ride in an actual airplane. If Mary follows her therapist's instructions, then she'll be engaged in ________.

Answers

Answer:

in vivo exposure therapy

Explanation:

This kind of therapy is based on the idea that the patient should face the trigger that produces discomfort. Although  it can be thought as a counterproductive kind of therapy, it is necessary to take into account that the professional should be very well prepared in order to recognized the level of anxiety the patient is going through when the in vivo exposure therapy is taking place, and it is possible to simply stop it when they consider it is not healthy for the patient.

On the other hand, the therapy is very well known to help patients facing diferent kinds of phobias and to be very successful.

The ACA (Affordable Care Act) was designed to __________.

Answers

Final answer:

The Affordable Care Act (ACA), also known as Obamacare, aimed to enhance access to health insurance, protect consumers, and reduce healthcare costs, while mandating individual and employer coverage and offering a standardized Marketplace for plan comparison.

Explanation:

The Purpose of the Affordable Care Act (ACA)

The Affordable Care Act (ACA), commonly known as Obamacare, was enacted with several key objectives. The ACA aimed to increase access to health care coverage, protect consumers from insurance practices that could either deny them necessary care or elevate the cost of that care to unaffordable levels, and reduce overall healthcare costs. A cornerstone feature of the ACA was the individual mandate, which required all Americans to have health insurance or face a penalty. As part of this effort, employers were mandated to provide health care coverage if they had a certain number of employees, while individuals were given the ability to purchase insurance through the Health Insurance Marketplace. This Marketplace offered standardized health insurance coverage plans to make it easier for consumers to compare options. Another significant aspect of the ACA was the expansion of Medicaid, aimed at increasing coverage among low-income individuals.

Through a combination of mandates, subsidies, and insurance reforms, the ACA sought to reduce the number of uninsured Americans, which dropped from 16% pre-ACA to approximately 8.5% after ACA implementation. Moreover, the ACA included provisions to ensure that subscribers could not be denied coverage based on pre-existing conditions and that a substantial portion of premium funds received by insurers went directly toward medical care.

A Wayne State University researcher and heart doctor has mapped Metro Detroit’s hypertension rates by census tract and layered it with social determinant data. Health providers and advocates hope this latest tool in "precision public health" may guide decisions about where and when to spend health care dollars for maximum impact.
Do you agree?

Answers

Answer and explanation:

I personally agree with the research presented above since geographic related data can help the government, no matter what country, to see the whole picture as to how long life expectancy is nowadays and how much of an impact lifestyle regarding socials status and economic issues has to do with it.

Constant stress because of financial problems and opportunities inequality in general play a major role on health deterioration. So, this way healthcare can be handled more diligently and develop a better disease control, not only on which are the areas that needs it the most but also what can the national administration do to prevent more health issues just because of social problems in the future, that being the main problem on this investigation.

The client with substance use disorder was found unconscious after overdosing on heroin 2 days prior. Because of prolonged pressure on the muscles the client has developed myoglobinuria, causing which complication?

Answers

Answer:

Obstruction of the renal tubules with myoglobin and damage tubular cells

Explanation:

Myoglobinuria is usually the result of the muscle destruction. Any process which can result in the interference of the muscle activity can lead to myoglobnuria.

It is usually associtaed with the increased level of the creatine kinase, lactate dehydrogenase and many other enzymes.

When it is passes from the renal tubules causes obstruction and acute kidney injury.

Which term refers to the surgical removal of a baby from the uterus?

stillbirth

cesarean section

premature birth

afterbirth

Answers

Answer is : cesarean section

The term for the surgical removal of a baby from the uterus is a cesarean section.

What is cesarean section?

Cesarean section procedure is typically performed when a vαginal birth is not possible or safe. It involves making a surgical incision in the mother's abdomen and uterus to deliver the baby. The terms stillbirth, premature birth, and afterbirth do not refer to this procedure.

A stillbirth refers to a baby born without signs of life at or after 20 weeks gestation. A premature birth is one that occurs before 37 weeks of pregnancy. The term afterbirth refers to the placenta and fetal membranes expelled from the uterus after childbirth.

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Melanie's therapist suggests that when she feels anxious, Melanie should attribute her arousal to her highly reactive nervous system and shift her attention to playing a game with her 5-year-old son. This suggestion best illustrates ____________.

Answers

Answer:

Cognitive Behavioral Therapy

Explanation:

Cognitive behavioral therapy is a short-term, goal-oriented psychotherapeutic treatment that aims to improve the mental health of a patient, by helping patients to understand the thoughts and feelings that influence their behaviors. It is also a practical approach to solving current problems of patients by developing personal coping strategies that tackles the emotional difficulties faced by patients.  This therapy focuses on an identified problem and further maps out an action step to take in ameliorating such problem.

The therapist employs the cognitive behavioral therapy in solving Melanie’s anxiety problem by assisting her in understanding that her behavior was as a result of her highly reactive nervous system. The therapist further suggests a practical effective strategy to address the issue by suggesting she plays a game with her 5-year-old son to shift her attention .

One of the greatest baseball players of all time was banned from the game for life after he and seven other players accepted bribes to throw a game in what year?

Answers

Answer and Explanation:

In the 1919 world series, the black Sox scandal occurred. Several white Sox players were accused of accepting bribe to lose the game which led go the appointment of the first commissioner of baseball Kenesaw Mountain Landis who presided over the case and banned all eight player including "Shoeless Joe" Jackson (who is regarded as the the greatest baseball player of all time) in the 1920 season from the MLB. the banned also prevented him from being inducted into the baseball hall of fame.

When an individual sustains blunt force trauma to the head that results in a brief disruption of the neural network without any physical evidence or lasting residual​ effects, this would be termed​ a:A. concussion.B. cerebral hematoma.C. brain contusion.D. herniation.

Answers

Answer: The answer is A. Concussion

Explanation:

In addition to the macronutrients it provides, the energy bar makes a significant contribution to meeting the Daily Value for several vitamins and minerals. What is a potential concern when consuming highly-fortified food products?

Answers

The correct answer would be, consuming multiple servings could lead to exceeding the Daily Value for some nutrients.

Explanation:

Energy bars are basically the food supplements that contain high energy foods to provide quick energy to people who do not have time for making and then eating meals.

Such energy bars give instant boost to the people consuming it. But consuming too many energy bars in a day may lead to an excess of the daily value for some nutrients. Everybody needs a specific amount of nutrients in a day. Exceeding these nutrients may cause disturbance in the body. For example, consuming too much fats may lead to obesity gradually. So even energy bars have to take in moderation.

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A company that manufactures drugs used to treat heart disease wants to determine if a new drug and exercise can affect cholesterol levels. What are the independent variable (IV) and the dependent variable (DV) in this proposed study?

Answers

Answer:

The dependent variable - the cholesterol level

Independent variables are the exercise and the drug.

Explanation:

A variable is a factor that can be modified or change. It is the factor that can be measured, altered, controlled in research or the experiment. It can be dependent or independent of their effect.

The independent variable is the factor of the experiment that controlled or manipulated by the researcher and it is considered to have a direct effect on the dependent variable whereas the dependent variable is being checked or tested.

So, in this experiment, the variable that is being tested is the cholesterol level that means it is a dependent variable. The independent variable here is exercise and drug as they manipulate and have an effect on the direct variable.

Thus, the correct answer is -

The dependent variable -the cholesterol level and  

independent variables - exercise and the drug.

Lance works in a​ fast-paced, noisy environment without air conditioning. His workspace is​ cramped, group leaders and other employees are constantly​ shouting, tools are humming and buzzing. Lance is likely to face stress caused by​ ____________.

Answers

Final answer:

Lance is likely to face stress caused by the specific stressors associated with his occupation, such as difficult working conditions, lack of positive feedback, work overload, and lack of support.

Explanation:

Lance is likely to face stress caused by the specific stressors associated with his occupation. These stressors can include challenging and unpleasant events such as difficult working conditions, lack of positive feedback, work overload, and lack of support. In Lance's case, his fast-paced and noisy environment, cramped workspace, constant shouting, and humming and buzzing tools contribute to his occupational stress.

Which best compares the male and female reproductive system? Select three options. The sperm duct and fallopian tube perform a similar function. The vagina and the penis are the last passageway out of the reproductive system. The glands of the male reproductive system have the same function as the uterus. The testes and ovaries perform a similar function. Testosterone is the dominant hormone in males and females.

Answers

The statement that best compares the male and female reproductive systems are as follows:

The sperm duct and fallopian tube perform a similar function.The vagina and the [tex]pen^is[/tex] are the last passageways out of the reproductive system.The testes and ovaries perform a similar function.

Thus, the correct options for this question are A, B, and D.

What do you mean by Reproductive system?

A reproductive system may be defined as a type of body system that significantly includes a group of organs and parts which function in reproduction consisting of the male and female with respect to their physiology and mechanisms.

The male reproductive system includes the testes which produce sperm, the [tex]pen^is[/tex], epididymis, vas deferens, ejaculatory ducts, and urethra. The female reproductive system consists of the ovaries which produce eggs or oocytes, fallopian tubes, uterus, cervix, vagina, and vulva.

Therefore, the correct options for this question are A, B, and D.

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Answer: abd

Explanation:

A recent study found that children with a high body mass index and waist circumference are at risk for _____ syndrome, a constellation of factors, including obesity, high blood pressure, and type II diabetes.

Answers

The answer is down the answer is down the answer is down

Polydactyly is the condition of having extra fingers or toes. Some polydactylous persons possess extra fingers or toes that are fully functional, whereas others possess only a small tag of extra skin. This is an example of

Answers

Answer:

variable expressivity

Explanation:

Variable expressivity is a phenomenon in genetics that quantifies the extent to which a particular genotype of an individual is being expressed phenotypically. This might be as a result of combination of genetic and environmental factors.

Variable expressivity is observed in people with polydactyly. The expression of people with this condition varies, as some persons possess extra fingers or toes that are fully functional, while others possess only a small tag of extra skin. Polydactylous people who have this same genetic condition expresses the condition phenotypically, differently.

During a feedback session, the nursing staff communicates that a recently appointed nurse is using "empowerment theory." Which statement of the nursing team members most supports this position?
a. "He/she can share power with others."
b. "He/she encourages others to provide input into decisions."
c. "He/she provides considerable information about the decision-making process."

Answers

Answer:

c. "He/she provides considerable information about the decision-making process."

Explanation:

“Empowerment” is a term used to conceptualizes the act or effect of promoting awareness and empowerment of a person or social group, usually to effect social, political, economic and cultural changes in the context that affects them.   Is to give tools to certain oppressed groups for them to have conditions and be able to be autonomous to develop themselves.

    The idea of empowerment is to give someone or a group the power of decision instead of overseeing it. The objective is to provide the necessary tools for this group to claim public policies that benefit or mitigate their specific difficulties.  

      For example, the black feminist movement,  works to empower black women by promoting awareness through community education, lectures and content production.

Consider the following family history: Bob has a genetic condition that affects his skin. Bob’s wife, Eleanor, has normal skin. No one in Eleanor’s family has ever had the skin condition. Bob and Eleanor have a large family. Of their eleven children, all six of their sons have normal skin, but all five of their daughters have the same skin condition as Bob.

Answers

Answer:

X chromosome is dominant.

Explanation:

Bob has X chromosome ( along with the genes ) and he passes them further to his female children, while the Y chromosomes are passed to his sons. As genes act in pairs, each female child gets each gene from both of their parents. That's why female children get genes from their fathers and sons get their genes from their mothers. In this case, Bob's X chromosome was more dominant and since it's a chromosome for formation of a female child, he passed it on to his female children, not male.

Antidiuretic hormone promotes the retention of water by stimulating

Answers

Answer:

The activation of the adenylate cyclase and therefore aquaporines

Explanation:

The anti diuretic hormone, also known as vasopressin, is produced in the hypothalamus where it’s released into the bloodstream throughly the axons and to the pituitary gland.

The main function of this hormone is to control blood pressure acting on kidneys and blood vessels, reducing the volume of water in urine by letting it go back into the body.

The anti diuretic hormone binds to the V receptor coupled to G in the principle cells located in the late distal tubule and collecting ducts. This ligation leads to the activation of the adenylate cyclase and finally the activation of aquaporines yo absorbe water into the cell.

I hope you find this information useful and interesting! Good luck!

The antidiuretic hormone promotes the retention of water by stimulating the permeability of the collecting duct to water.

What is the antidiuretic hormone?

The antidiuretic hormone can be considered as a chemical messenger used by the body to control the amount of water.

The antidiuretic hormone controls the amount of water reabsorbed by the kidneys' ducts during filtration.

The antidiuretic hormone is abbreviated as ADH and is also known as arginine vasopressin.

In conclusion, the antidiuretic hormone promotes the retention of water by stimulating the permeability of the collecting duct to water.

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Jasmine is a teenager who has been diagnosed with anorexia nervosa. What percentage of individuals with anorexia that receive treatment make a recovery?

Answers

Answer:

The correct answer is - 40 to 60%.

Explanation:

Anorexia nervosa is a disorder of eating that is characterized by a distorted body appearance, not able to gain appropriate weight gain in teens and growing children with an unwarranted fear of being obese. It can be stated as being obsessed with the weight and what an individual is eating.

Reports show that with the proper treatment, only 40 to 60% of individuals with this disorder makes full recovery and spend a life with no thoughts or behaviors related to the anorexia nervousa.

Thus, the correct answer is - 40% to 60%.

Stephanie experiences paralysis to the left side of her body as a result of a horrible four-wheel accident. According to Stephanie, she is able to move both her left arm and leg. Stephanie experienced damage to her ____.

Answers

Answer:

Stephanie experiences paralysis to the left side of her body as a result of a horrible four-wheel accident. According to Stephanie, she is able to move both her left arm and leg. Stephanie experienced damage to her __right hemisphere__.

Explanation:

The right hemisphere basically controls and coordinates the activities associated with the left part of the body. Activities such as art and creativity.

An occupational therapist plans a task-oriented activity group for adolescent girls recently diagnosed with anorexia nervosa. Which is the best activity for the therapist to include in the initial session of this group?

Answers

The correct answer would be, Composing lyrics and melody for a group song.

Composing lyrics and melody for a group song is the best activity for the therapist to include in the initial session of this group.

Explanation:

Occupational Therapist is a therapist who treat ill, disabled people through the use of different therapies. With the help of different therapies, the occupational therapists help these patients to develop, recover and maintain the skills required to perform the daily working activities.

So while treating a group of adolescent girls who are diagnosed with the Anorexia Nervosa, the therapist plans a task oriented activity. The patients with the problem of Anorexia have lack of appetite. They are in a misconception that they are obese and will gain weight if eat anything.

So to start the therapy for such people, the therapist should give them a soothing and relaxing start by engaging them in an activity that will relax their minds. so composing lyrics and melody for a group song would be a best group activity for such patients.

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What kind of conditions occurs when the bronchial tubes are inflamed and coughing, often with mucus.

Answers

Answer:

The conditions can lead to chronic bronchitis.

Explanation:

The lungs airways like bronchial tube become inflamed and causes symptoms like coughing can lead to a condition called bronchitis. The severe form of the condition can cause acute form to chronic bronchitis. The person suffers from acute bronchitis recovers their health within few days. This can be caused by viral infections. The cough for months is a sign of chronic bronchitis. It takes years to recover. the inflammed linning of passage of lungs releases excess mucus. Smoking is a major cause of chronic bronchitis in men.

The parent of an infant who developed hydrocephalus while in utero is very concerned that the child will have significant intellectual dysfunction. The best response to the parent would be:

Answers

Answer and Explanation:

  Hydrocephalus is characterized by fluid accumulation in the head. The excess retention causes the cerebral ventricles to dilate, causing damage to the brain structures.  Hydrocephalus can be congenital or acquired.

   The congenital form is present at birth but can be identified while in utero or manifest only during the first months of life. Although it is not always possible to determine the exact cause of the disorder, it is certain that genetic and hereditary factors are involved, as well as the occurrence of infectious diseases (toxoplasmosis, cytomegalovirus, rubella, syphilis, meningitis, etc.), and drug use ( cocaine, for example) during pregnancy.

   In addition to physical signs, the physician considers the patient's clinical history and the neurological evaluation. It is crucial to note that the sooner the diagnosis is made, the lower the risk of brain damage.  

The nurse is reinforcing teaching with a group of caregivers of children diagnosed with iron-deficiency anemia. One of the caregivers tells the group, "I give my child ferrous sulfate." Which statement made by the caregivers is correct regarding giving ferrous sulfate?

Answers

Answer:

"My husband gives our daughter orange juice when she takes her ferrous sulfate, so she gets Vitamin C."

Explanation:

Ferrous sulfate should be taken into the system between meals. It's preferable that it's taken with juice, especially orange juice because it is rich in vitamin C, which helps with absorption of iron.  It should not be taken in the system while eating a meal for one reason -- it causes constipation and there is a possibility that a child's stool would get black color.

Shreen is diagnosed with schizophrenia. She believes that she is a powerful person who can save the world. Shreen is experiencing __________.

Answers

Answer:

Delusions of grandeur

Explanation:

Final answer:

Shreen is experiencing a grandiose delusion, which is a type of delusion common in people diagnosed with schizophrenia. These delusions involve beliefs of extraordinary power or importance. This is a symptom of her illness and requires professional medical supervision and management.

Explanation:

Shreen is experiencing a psychological symptom known as a grandiose delusion. This symptom is common in individuals diagnosed with schizophrenia. Grandiose delusions are characterized by beliefs that one holds special power, unique knowledge, or extremely important. For instance, believing that one is a powerful person who can save the world indicates a grandiose delusion. It's important to recognize that these beliefs are a product of the illness and do not reflect the individual's actual abilities or circumstances.

Delusions can be challenging to live with and manage. They often interrupt day-to-day function and may lead to rapid mood swings or other sociopsychological challenges. An individual with schizophrenia may require consistent, professional, healthcare supervision and effectual medication for the management of grandiose delusions and other symptoms.

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