A company that makes a type of medicine used to treat malaria is changing the dosage, or amount, that it recommends people take. Instead of
one pill per day, the company has found that it is more effective to take two pills per day. What steps would they need to go through before they
would be allowed to change the dosage information on their package?
OA They would need to provide data to the FDA and get approval.
OB. They would need to call all the pharmacies and ask them to write the new dosage on their bottles.
OC. They would need to invite the NIH to their factory to see the process to create the pills.
OD. They would need to contact the CDC and tell them about the dosage change.

Answers

Answer 1

Steps would they need to go through is they would need to provide data to the FDA and get approved.

The FDA or Food and Drugs Administration is a federal body or agency by the health department that regulates any approval or changes in any food or drug product.

Any change, be it change in the size, weight, color, packaging, or even the dosage of any drug is regulated by the FDA.

Everything related to the food or drug products needs a proper approval from this body.

When a pharmaceutical company need to change anything regarding the drug, maybe its packaging, dosage, mode of administration, etc; it needs to follow the FDA’s exact procedure to get it done.

It is illegal for any company to make changes in their products without the permission of FDA.

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Related Questions

The nurse is using the pediatric glasgow coma scale to assess a child's level of consciousness. What would the nurse assess? select all that apply

Answers

The nurse that is using the pediatric glasgow coma scale should assess the Eye opening, Verbal response and Motor response.

What is pediatric glasgow coma scale?

The pediatric glasgow coma scale is a type of scale that is used to evaluate the level of consciousness using three parts such as:

eye opening,

verbal response, and

motor response.

Therefore, the nurse that is using the pediatric glasgow coma scale should assess the Eye opening, Verbal response and Motor response.

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at what gestational age is the fetus generally considered to be viable?

Answers

A fetus is considered viable as early as 24 weeks.

Age of viability of fetuses

A fetus is formed from a zygote.

A fetus is considered viable when it can survive and become a normal human irrespective of whether it gets to the required gestation period before being delivered.

This period has been found to be as early as the 24th week after fertilization.

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A client has been diagnosed with systolic heart failure. what percentage will the nurse expect the patient’s ejection fraction to be?

Answers

The percentage which the nurse will expect the patient’s ejection fraction to be is 40 percent or less.

What is Systolic heart failure?

This condition occurs when the ventricle loses its ability to contract normally thereby leading to heart failure.

The normal ejection is 55 percent but a systolic heart failure means it has been reduced to 40 percent or less.

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how might a surgeon best handle a patient’s request to bring a totem from his spirit animal into the or?

Answers

The surgeon should politely inform the patient that only healthcare professionals and the patient are allowed into the operating room (OR).

What is an OR?

OR is a medical acronym for operating room and it can be defined as a facility in an hospital that is equipped for the performance of surgery on a sick patient.

Based on standard hospital policies and protocols, the surgeon should politely and respectfully inform the patient that only healthcare and the patient are allowed into the operating room (OR).

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Other than abstinence, what contraceptive method is most effective against hiv if used properly?.

Answers

Other than abstinence, latex condoms are most effective against hiv and other STDs.

hich initiatives are pillars of the Let’s Move! program? Select three options.

increasing physical activity
providing more snack times in schools
creating a healthy start for children
empowering parents and caregivers
providing children with vitamin supplements

Answers

1. Creating a healthy start for children
2. Empowering parents & caregivers
3. Increasing physical activity

The following initiatives make up the lets move program's cornerstones:

raising the level of exercise

giving children a healthy start

enhancing parental and caregiver control.

thus option A, C and D initiatives are pillars of the Let’s Move! program.

How do the let's move program work?

This might be referred to as a public health initiative that was started by Michelle Obama, the former first lady of the United States.

The program's goal was to combat childhood obesity in early childhood and encourage them to maintain a healthy lifestyle.

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A certain joint in the body has an articular capsule. this joint must be a/an:

Answers

A certain joint in the body that has an articular capsule must be diarthrosis and synovial.

What is diarthrosis?

Diarthrosis can be defined as a special class of articulation joint that undergoes free motion/movement.

Moreover, a joint in the body that is contained in an articular capsule is a synovial articulation.

In conclusion, a certain joint in the body that has an articular capsule must be diarthrosis and synovial.

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I don’t know how to fill this out HOPE

Answers

It should be just enough to increase the stretch in the quad. Hold for 2 seconds then straighten the knee. Perform 10-15 repetitions.

Explanation:

if it doesn't help add me on discord EthDaGamer#0980

The plasma membrane of cells lining the small intestine has ___________ which are specialize for absorption of nutrients

Answers

The plasma membrane of cells lining the small intestine has villi which are specialize for absorption of nutrients.

What is villi?

Villi is small projection from a membrane, particularly those found in the mucous membranes of the intestines.

The small intestine is the known to be the site of absorption of nutrients in humans and other living organisms.

This is because the plasma membrane of cells lining the small intestine has villi which are specialize for absorption of nutrients.

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state the importance of regular health examination.

Answers

Reduce your risk of getting sick. Detect potentially life-threatening health conditions or diseases early. Increase chances for treatment and cure. Limit risk of complications by closely monitoring existing conditions.

Explanation:

To make our body healthy and to be safe from different kind of diseases and infirmities, we should consult a doctor for regular check ups. Sometimes we become weak and ill due to various reason. So we should get our body checked regularly...

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Question 13 of 32
Which of the following is an example of a healthy dating relationship?
OA. One person convinces the other that they are meant to be together
forever.
B. One person insists that they split the check for a meal.
OC. One person insists that he or she get a goodnight kiss.
OD. One person pressures the other into stepping outside his or her
comfort zone.
SUBMIT

Answers

None really, but b is the best option
B is the best option

ich topics and guidelines fall into four main categories:

Answers

The ICH has four main guidelines that are based on the quality, safety, efficacy and multidisciplinarity of clinical studies (Good Clinical Practices - BCP).

What is ICH?

Is an international standard of ethics and scientific quality for

designingconductingrecording and reporting

trials involving the participation of human subjects. Compliance with this standard provides a public guarantee that the rights, safety and well-being of trial participants are protected, consistent with the principles that have their origin in the Declaration of Helsinki, and that clinical trial data have credibility.

With this information, we can conclude that the ICH has four main guidelines that are based on the quality, safety, efficacy and multidisciplinarity of clinical studies (Good Clinical Practices - BCP).

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There are a variety of treatments available for people struggling with drug abuse. one type of treatment includes withdrawing gradually but completely from drug use.

which treatment best describes this process?

Answers

Medicine and counseling

the nurse is caring for a 10-year-old girl with cystic fibrosis who receives pancreatic enzymes. which comment by a parent demonstrates understanding of the instructions regarding the medication?

Answers

The comment by a parent that demonstrates understanding of the instructions regarding the medication is should give the enzymes before each meal or snack."

What is cystic fibrosis?

Cystic fibrosis refer to a medical conditions that is inherited or genetically transfered which affect the lungs and digestive system of the patient.

Therefore, The comment by a parent that demonstrates understanding of the instructions regarding the medication is should give the enzymes before each meal or snack."

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after percutaneous transluminal coronary angioplasty (ptca), the nurse confirms that a client is experiencing bleeding from the femoral site. what will be the nurse's initial action?

Answers

The nurse's initial action will be to apply manual pressure at the site of sheath insertion.

What is percutaneous transluminal coronary angioplasty?

Percutaneous transluminal coronary angioplasty (PTCA) is a medical procedure aimed at improving blood flow in the heart.

This medical procedure (PTCA) enables to narrow coronary heart arteries and thus blood flow improves.

In conclusion, the nurse's initial action will be to apply manual pressure at the site of sheath insertion.

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Which factor is related to seat belt use in teens?

A. Type of vehicle
B. Weather conditions
C. Alcohol use
D. Speed limit on roadways

PLEASE HELP

Answers

Answer:

The correct answer is D, speed limit on roadways.

Explanation:

According to a study held in 2009, there were more teens who crashed during weather related incidents. The teens who were wearing a seatbelt did not suffer any fatalities. Other factors including speed limits, and law enforcement spending. It is against the law in the United States to drive without a seat belt. All passengers need to be in a seatbelt or properly installed device such as a car seat.

The weather is another huge factor for a person to wear seatbelts. Hydroplaning is common when there is standing water on roads, and a seat belt can safe your life when the car spirals out of control on wet roadways. Snow and ice are other reasons you would want to wear seatbelts. Many cars leave the road when they slide off, and wearing a seatbelt will help to save lives during these types of weather related incidents. But that is not the answer.

Answer:

I feel the most likely answers would be A or D but then again your question is very confusing. do you have more context?

(edited)

Explain how alcohol affects the body and the brain

Answers

Alcohol slows down your body
Alcohol interferes with the brain's communication pathways, and can affect the way the brain works. Alcohol’s disruptions to your brain can change your mood and behavior drastically, as well as slow your body’s thought process down, making it difficult to think clearly.

anthropologist scott hutson (2000) describes similarities between the altered states of consciousness and ""self-forgetting"" of shamans and a similar experience of participants of:

Answers

Anthropologist Scott Hutson describes similarities between the altered states of consciousness and ""self-forgetting"" of shamans and a similar experience of participants of raves.

What is anthropology?

Anthropology is the study of human societies, their cultures and beliefs as a well as how these developed.

Anthropologist Scott Hutson describes similarities between the altered states of consciousness and ""self-forgetting"" of shamans and a similar experience of participants of raves.

A rave is a dance party with loud music and often use of hallucinogenic drugs.

In many raves, individuals demonstrate altered states of consciousness and ""self-forgetting"".

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How long is buttermilk good for after expiration date.

Answers

Answer:

if opened it’s good for 7-14 days

If unopened it’s good for 14 days

Hipaa which term refers to an organization’s ability to share phi with other individuals if they believe it is in the best interest of the patient or they believe the patient would not object?

Answers

For an organization to disclose a protected information about a patient, it must be in the best interest of the patient.

What does PHI stand for?

PHI stands for Protected Health Information.

The HIPAA Privacy Rule provides federal protections for personal health information held by covered entities and gives patients an array of rights with respect to that information.

Thus, for an organization to disclose such protected information about a patient, it must be in the best interest of the patient.

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the yeast candida albicans does not normally cause disease because of:

Answers

The yeast Candida Albicans does not normally cause disease because of antagonistic bacteria.

What are antagonistic bacteria?

Antagonistic bacteria are bacteria that work against the survival of other pathogens in a suitable host.

This interaction (antagonism) may result very useful for human hosts to avoid disease states.

In conclusion, the yeast Candida Albicans does not normally cause disease because of antagonistic bacteria.

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disscuss cellular structure of corona virus with diagram and name of differnt vaccines

Answers

The corona virus contains a spike (S) protein on its surface which uses to enter into cells, it is the primary target for already developed vaccines against this disease.

Why spike protein is important to fight against corona virus?

The spike (S) protein is a trans-membrane protein present on the viral envelope, which is required to enter the cell by binding to the ACE2 receptor.

All vaccines developed until now are based on boosting the immune system to develop antibodies against specific antigens present in the S protein.

The main classes of vaccines to fight against this virus include:

Viral vector vaccines (e.g., AstraZeneca)Messenger RNA vaccines (e.g., Pfizer)Attenuated vaccines (e.g., Sinopharm)

In conclusion, corona virus contains a spike S protein that is the primary target for already developed vaccines against this disease.

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In 1990, three out of the top seven causes of death around the world were NCDs, but by 2015 that number grew to ____ out of the top seven causes of death.

Answers

In 1990, three of the seven leading causes of death worldwide were NCDs, but by 2015 this number had grown to 5 of the seven leading causes of death.

What are the main NCDs?

Non-communicable chronic diseases (NCDs) are the leading cause of death and disability worldwide. They include five major disease groups:

cardiovascularchronic respiratorycancerdiabetesand mental and neurological conditions.

With this information, we can conclude that in 1990, three of the seven leading causes of death worldwide were NCDs, but by 2015 this number had grown to 5 of the seven leading causes of death.

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stephanie properly opened the airway and delivered ventilations. which statement about delivering ventilations to an infant in cardiac arrest is true?

Answers

When using a BVM, depress the bag about halfway to make the chest begin to rise.

What is cardiac arrest?

The term cardiac arrest refers to the sudden stoppage of the functions of the heart. It is caused by an irregular rhythm of the heart.

The true statement about delivering ventilations to an infant in cardiac arrest is; "when using a BVM, depress the bag about halfway to make the chest begin to rise."

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What aspects of your life (such as family, community, heredity) help you avoid self-destructive actions and peer pressure to engage in those actions? what aspects make it difficult to resist peer pressure to engage in destructive actions?

Answers

The aspects of our lives that help us to avoid self-destructive actions and peer pressure to engage in these actions are the right education, safe environment and psychological support.

The aspects that make it difficult to resist peer pressure to engage in destructive actions are lack of family support, search for social relevance among friends, etc.

How should parents and teachers help students who give in to peer pressure?

Dealing with peer pressure

In adolescence, participation in a social group has enormous relevance.Saying “no” on time can keep your kids away from negative influences.Fostering self-esteem from an early age will help children to be part of a group and make appropriate choices.

With this information, we can conclude that the aspects of our lives that help us to avoid self-destructive actions and peer pressure to engage in these actions are the right education, safe environment and psychological support.

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the complementary and alternative medicine therapy that involves the use of highly diluted extracts that would in larger quantities produce the symptoms of an illness is:

Answers

The complementary/alternative medicine therapy that involves the use of highly diluted extracts that would in larger quantities produce illness is Homeopathy.

What is Homeopathy?

Homeopathy is a medical strategy considered an alternative form of medicine by many people.

This strategy (Homeopathy) is focused on the use of extracts, e.g., plant extracts, in order to cure and prevent diseases.

In conclusion, the complementary medicine therapy that involves the use of highly diluted extracts that would in larger quantities produce illness is Homeopathy.

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understanding of the stress and anxiety relationship with risk of athletic injury is based on _________ research.

Answers

Understanding the stress and anxiety relationship with the risk of athletic injury is based on correlational research.

What is correlational research?

Correlational research is a  type of investigation where one variable is estimated on the basis of another related variable.

This type of investigation (correlational research) may result very useful to predict the value of a variable.

In conclusion, understanding the stress and anxiety relationship with the risk of athletic injury is based on correlational research.

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The buildup of fatty tissues in the heart makes it more difficult for the heart to function.
a) true
b) false

Answers

Answer:

the answer is true

PLEASE HELP!!!!!!

Which statement is FALSE?
A. Some research suggests that physical activity in childhood might increase the brain's resilience later in life.
B. Physical activity and play during early childhood have a vital role in sensory and physiological stimulation, resulting in more
synapses being formed in the brain.
C. The brain's left side controls the body's right side, and the brain's right side controls the body's left side.
D. Cross-lateral activities are the ONLY ones that develop permanent synapses.

Answers

Pretty sure it’s D :/

I will give 85 points and whatever else you ask for. Research California's laws about se-xual harassment and se-xual assault. You need to write one paragraph summarizing these laws in your own words. Be sure to include information about laws concerning se-xual harassment, age of consent, and ra-pe. Thankyou

Answers

In California, some of the laws regarding se×ual harassment and assault against a person include: Misdemeanor se×ual harassment and assault is punishable by up to six (6) months or one (1) year in county jail.

A fine of up to $2,000 may be charged for misdemeanour se×ual harassment and assault.A felony conviction for se×ual harassment and assault is punishable by up four (4) years in county jail.A fine of up to $2,000 may be charged for misdemeanour se×ual harassment and assault in California.

What is Equality of opportunity?

Equality of opportunity simply refers to a state of fairness and political ideal in which all individuals that are living within a country are treated similarly and fairly, without any form of bias, se×ual harassment and assault, racism, discrimination, and prejudice.

Thus, this could be the answer.

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Find two positive numbers such that their sum is 60 and their product is a maximum. Select one: O a. 30 and 30 O b. 25 and 35 O c. 1 and 59 O d. 20 and 40 Listeners that are not able to look beyond the stated words and/or nonverbal cues of a speaker to understand the real meaning are called ________________. Find the distance between -6.77777 and 3.55555.O 10.3O 10.33332O 10.333333213.33332 EEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEE I NEED HELP Two masses, m and 2m, approach each along a path at right angles to each other. After collision, they stick together and move of at 2m/s at angle 37 to the original direction of the mass m. What where the initial speeds of the two particles? Which word is the best synonym for bulwark a. castleb. rampartc. breakwater A man walks 30 m to the west, then 5 m to the east in 45 seconds.a. What is his displacement? b. What was his total distance walked? c. What is his average velocity? What is the solution to the linear equation?8-10-28+7=8+d-10-360 d=-5O d=10 d=5Mark this and returSave and ExitNextSubmit Using another product , for example , bread or clay pots , explain , with simple illustrations , how division of labour or specialisation could be used to make the product . write a short note on the introduction of the basic democracies system 1959 A negative number raised to an odd power is_____ negative.alwaysneversometimes Katie designed an experiment using a paint roller pan, sand, and water. The steps of the experiment are listed below.1:Put 3 inches of moist sand on a paint roller pan.2:Make a beach by scooping the sand towards the higher portion of the pan.3:Put some soil with very small plants growing on it on the sand.4:Pour water into the deeper end of the pan.5:Move the roller pan to create wave like motion in the water.6:Observe how the sand and plants are displaced by the waves.Katies model most likely represents the interactions between theA: atmosphere, ocean and cryosphereB: geosphere, ocean, and biosphereC: atmosphere, ocean, and biosphereD: cryosphere, biosphere, and ocean 5. How does international employment help to improve economic condition of the country? 4. At times, a main idea may cover more than one paragraph. The main idea of paragraphs 3 and 4 is stated in the A. first sentence of paragraph 3.B. second sentence of paragraph 3.C. first sentence of paragraph 4. D. last sentence of paragraph 4. How did the Cold War affect the United States? And how did it affect the Soviet Union? today is January 15 and we view a 1st quarter moon, on what date will we observe a third quarter moon What is the empirical formula for a compound composed of 0.0683 mol of carbon ( C ), 0.0341 mol of hydrogen ( H ), and 0.1024 mol of nitrogen ( N )? i need help asappppp Which athlete received the largest contract in the history of sports?. Which of the following is the best definition of a physical change?A. A change in a substance where a new substance is formedB. A change in a substance in which mass is conservedC. A change in a substance inwhich bonds are brokenD. A change in a substance with no new substances being formed