An investigator proposes to study a market approved product sold to treat high blood pressure in individuals over age 12. This study will look at using a liquid formulation for children under age 12. The drug sponsor hopes that the information from the research can be used to change the labeling for use of the drug in children. Which of the following is the investigator’s most appropriate course of action?
A) Submit the research protocol to OHRP for their review
B) Submit the research protocol to the IRB, but do not submit an IND application to the FDA since the drug is already approved and marketed for this indication.
C) Submit the research protocol to the IRB for review and submit an IND application to the FDA before conducting research.
D) Submit an Investigational Device Exemption (IDE) application to the FDA.

Answers

Answer 1

Answer: Submit the research protocol to the IRB for review and submit an IND application to the FDA before conducting the research

Explanation:

From the question, we are informed that an investigator proposes to study a market approved product sold to treat high blood pressure in individuals over age 12 and that this study will look at using a liquid formulation for children under age 12.

We are further told that the drug sponsor hopes that the information from the research can be used to change the labeling for use of the drug in children.

The investigator’s most appropriate course of action will be to submit the research protocol to the IRB for review and submit an IND application to the FDA before conducting research.


Related Questions

Rovinsky Corporation, a company that produces and sells a single product, has provided its contribution format income statement for November. Sales (7,300 units) $ 350,400 Variable expenses 204,400 Contribution margin 146,000 Fixed expenses 103,500 Net operating income $ 42,500 If the company sells 7,200 units, its net operating income should be closest to:

Answers

Answer:

Net operating income= 40,500

Explanation:

Giving the following information:

Contribution margin 146,000

Fixed expenses 103,500

Sales= 7,200

First, we need to calculate the unitary contribution margin:

Unitary contribution margin= 146,000/7,300= $20

Now, for 7,200:

Total contribution margin= 7,200*20= 144,000

Fixed costs= (103,500)

Net operating income= 40,500

Links Cable Network has decided to offer a one-hour appointment window for customers needing installation or repair of its service, which will require the company to have several technicians on call. Links hopes this practice will give it an advantage over the competition, none of which have adopted such a practice. Links Cable Network is introducing a(n) ______ change.

Answers

Answer:

Radically innovative.

Explanation:

In this scenario, Links Cable Network has decided to offer a one-hour appointment window for customers needing installation or repair of its service, which will require the company to have several technicians on call. Links hopes this practice will give it an advantage over the competition, none of which have adopted such a practice. Links Cable Network is introducing a radically innovative change.

A radically innovative change is a strategic business approach aimed at developing the business drastically.

Land is purchased for $256,000. Additional costs include a $15,300 fee to a broker, a survey fee of $2,400, $1,750 to construct a fence, and a legal fee of $8,500. What is the cost of the land

Answers

Answer:

The answer is $282,200

Explanation:

The cost of an asset includes the purchase price (cost of acquisition) and the cost neccessary to bring it usage.

For example, for cost of acquiring a machinery, the purchase price minus any trade discount plus cost of transportation, plus any tax paid on acquisition plus cost of installation etc.

But for the acquisition of land, all the cost except the cost of fence of the land will be considered.

So we have:

Purchase price. $256,000

Broker's fee. $15,300

Survey fee. $2,400

Legal fee $8,500

Cost of the land. $282,200

intext:"A company has 50,000 shares of common stock outstanding. The stockholders' equity applicable to common shares is $1,470,000, and the par value per common share is $5. The book value per share is"

Answers

Answer:

$29.4 per share

Explanation:

A company has 50,000 shares of common stock outstanding

The stockholder's equity that is applicable to common shares is $1,470,000

The per value of common share is $5

Therefore, the book value per share can be calculated as follows

= $1,470,000/50,000

= $29.4 per share

Hence the book value per share is $29.4 per share

On January 15, 2021, Bella Vista Company enters into a contract to build custom equipment for ABC Carpet Company. The contract specifies a delivery date of March 1. The equipment was delivered on March 31. The contract requires full payment of $75,000 30 days after delivery. The revenue for this contract should be recorded on

Answers

Answer:

31 March 2021

Explanation:

The contract should be recorded on 31 March 2021 because according to the US Generally Accepted Accounting Principles, revenue should be recognize in the book only when service has been rendered to the customer, the selling price of product is fixed and confirmation of service arrangement and amount to be collected.

With regards to the above scenario, since the equipment was not delivered until 31 March, then 31 of March will be recognized.

Jennifer is a junior in college. Her current cumulative grade point average (GPA) is 3.5 out of a 4.0 scale. Jennifer is hoping that by the time she graduates, she can raise her cumulative GPA to a 3.7. Which of the following statements is correct?A. Either b or c could be correct. B. If Jennifer earns a 3.7 GPA in her senior year, she will be able to raise her cumulative GPA to a 3.7. C. If Jennifer earns between a 3.5 and a 3.7 GPA in her senior year, she will be able to raise her cumulative GPA to a 3.7. D. Jennifer must earn above a 3.7 GPA in her senior year in order to raise her cumulative GPA to a 3.7.

Answers

Answer: d. Jennifer must earn above a 3.7 GPA in her senior year in order to raise her cumulative GPA to a 3.7.

Explanation:

Calculating and aiming for improved gpa towards the end of a session has to go alongside improvement in performance from the individual. Jennifer's target here is a minimum of a 3.7cgpa while Curren at 3.5cgpa, for Jennifer to achieve this she has to improve her effort, scoring anything below 3.7 would not take her towards 3 .7,a 3.5 or 3.6 will further reduce the possibility.

A donor gave $75,000 to a nongovernmental, not-for-profit charity with instructions that the funds be transferred to Sam Smith, an individual who lost his home in a fire. The not-for-profit would:

Answers

Answer:

B) Record the $75,000 cash and credit a liability

Explanation:

Possible options:

A) Record the $75,000 cash and credit temporarily restricted revenue. B) Record the $75,000 cash and credit a liability C) Do either (a) or (b), depending upon the policy of the not-for-profit D) Not record the transaction.

Non-for-profit charities must record all cash donations, but since the funds were donated for an specific purpose, their use is restricted. Therefore, the charity must record a liability (which has a normal credit balance).

Jose Suarez has been hired as sales manager at a new firm and is trying to come up with a sales force compensation method. He would like to have selling expenses relate directly to sales resources, an aggressive sales force, and minimization of non-selling tasks. What compensation method(s) would best fulfill his requirements

Answers

Answer:

straight commission

Explanation:

Straight commission refers to the commission in which only a sales percentage could be given in terms of commission no extra payment, no salary is given. The percentage could be based on the performance of the salesperson i.e how much sales he sold so according to that the percentage is given

Therefore the given situation represents the straight commission method

Keith and his team,employees of an online retailing company,are being trained on cyber surveillance and user security.As part of their training,they are working to identify a solution to the problem of cyber-phishing and data breaches.Which of the following forms of group-building methods is being employed by Keith's team?A) Cross-learningB) Action learningC) Adventure learningD) Virtual realityE) Behavior modeling

Answers

Answer: Action learning

Explanation:

From the question, we are informed that Keith and his team, employees of an online retailing company, are being trained on cyber surveillance and user security and as part of their training, they are working to identify a solution to the problem of cyber-phishing and data breaches.

The method used is action learning. This means that the group will get an actual problem, solve it, plan and the results will be shown to the team and the organization.

​Harley-Davidson disciples share a​ common, deeply held attraction to the brand. Harley appeals​ include: freedom,​ independence, power, and authenticity.​ Harley-Davidson doesn't just sell motorcycles. It sells​ self-expression, lifestyles,​ aspirations, and dreams. This illustrates​ core customer values

Answers

Answer: Brand personality

Explanation:

Brand personality is what the customers can easily relate to about a particular brand. To develop and maintain a strong brand, having a brand personality is vital.

From the question, we are informed that Harley appeals​ include freedom,​ independence, power, and authenticity and that Harley-Davidson doesn't just sell motorcycles, it sells​ self-expression, lifestyles,​ aspirations, and dreams. This illustrates brand personality.

True, its illustrated Core Customer Value.

Core customer values refers to the perception of what a product or service of a company is worth to a customer against the effort of buying such product.

These values are what attracts customers to a product or a firm.

Question sometime asked by customer that what do i gain from this product despite being costlier? The Core values the customer got from the product or firm keeps the attraction.

In conclusion, the values are displayed effectively by product or firms in other to persuade new customer as well as to attract existing customers.

Learn more about Core customer values here

brainly.com/question/15073502

"Jobs Now is an employment website. Like its competitors, it offers free listings in every category, which is free for job seekers but not for companies. This feature of Jobs Now is an example of"

Answers

Answer:

A revenue model

Explanation:

A revenue model is a business organizational framework and strategy  for balancing a business expenditure and income generation per revenue stream outlined by the business by identification of the veritable revenue sources, the structure of the pricing for the access to the value derived from the revenue source, as well as how customers are to pay for the value of the services of the revenue source

In essence, a revenue model maps value to buyers of a given valuable product.

The quantity of money has no real impact on things people really care about like whether or not they have a job. Most economists would agree that this statement is appropriate concerning Group of answer choices both the short run and the long run. the short run, but not the long run. the long run, but not the short run. neither the long run nor the short run.

Answers

Answer:

the long run, but not the short run.

Explanation:

Most people would like to earn a lot of money but it's unclear about the advantages of earning a large salary. They can afford more pleasures once they get rich, but a recent study indicates wealthier people seem to be less able to cherish the little things in life. Economist suggests that once reaching a threshold the quantity of money don't interest the people anymore but this is a case when wealth is acquired in a long period. People to fulfill their immediate goals gave significant importance to the quantity of money.

Claire Nevsky is in charge of advertising for her company and has produced a 30-second television spot to promote one of the company's new products. One of her assistants just out of college believes that the commercial has too much visual and audio information packed into such a small amount of time. The assistant is specifically concerned about limits in the receiver's

Answers

Answer:

Channel capacity

Explanation:

The channel capacity is the rate in which the data and information could be converted through a channel of communication

Here, in the given question as it is mentioned that the commercial includes more visual and audio information that to be converted into a less amount of time so this determines the channel capacity for the limits

Carfax offers a report on used cars for $39.99. It details the ownership type and history, vehicle mileage, accident reports, and other information. Carfax is an example of how markets try to:

Answers

Answer:

lessen the lemons problem by reducing asymmetric information.

Explanation:

Since in the question it is mentioned that the Carfax offered a report on a cars that are used for $39.99. The information involves type of ownership, history, vehicle mileage, accident reports, and other type of information

Based on the above information, the markets lowered the lemon problem i.e. asymmetric information that represents the failure of information

Hayduke Corporation reported the following results from the sale of 5,000 units in May: sales $300,000, variable costs $180,000, fixed costs $90,000, and net income $30,000. Assume that Hayduke increases the selling price by 5% on June 1. How many units will have to be sold in June to maintain the same level of net income?

Answers

Answer:

4,444.44 units

Explanation:

For the computation of Number of units to be sold to earn target profit first we need to follow some steps which are shown below:-

Selling price per unit = Sales ÷ Number of units sold

= $300,000 ÷ 5,000

= $60

Variable cost per unit = Total variable cost ÷ Number of units sold

= $180,000 ÷ 5,000

= $36

Increase in selling price = $60 × 5%

= $3

New selling price per unit = $60 + $3

= $63

New contribution margin per unit = New selling price per unit - Variable cost per unit

= $63 - $36

= $27

Number of units to be sold to earn target profit = (Fixed cost + Target profit) ÷ Contribution margin per unit

= ($90,000 + $30,000) ÷ $27

= $120,000 ÷ $27

= 4,444.44 units

On Monday, the seller offers to sell his vacant lot to the buyer for $42,000. On Tuesday, the buyer counteroffers to buy for $40,500. On Friday, the buyer learns that several other prospects may be making offers on the property, so he withdraws the counteroffer and agrees to the original asking price of $42,000. Under these conditions, there is

Answers

Answer:

b. not a valid agreement because the buyer's counteroffer was a rejection of the seller's offer, and once rejected, an offer cannot be accepted later.

Explanation:

Since in the question it is mentioned that the vacant lot is offered for $42,000 but the buyer counteroffers to buy $40,500 but afterward he agreed to the original price of $42,000

So this situation represents that it is not a valid agreement as the counteroffer made by the buyer was rejected by the seller and once it is rejected then the same could not be accepted

Therefore the correct option is b.  

Suppose there are 1000 firms in a market and all are identical. Firm A will hire 20 workers when the wage rate is $10, 25 workers when the wage rate is $9, and 30 workers when the wage rate is $8. The equilibrium wage rate for a number of years has been $9. If the wage rate falls to $8, we know that

Answers

Answer:

d. the quantity demanded for the market will increase to less than 30,000 workers.

Explanation:

Missing options:

a. the quantity demanded for the market will increase to 30,000 workers. b. the quantity demanded for the market will increase to more than 30,000 workers. c. the quantity demanded for the market will increase, but we can't tell which of the above answers is correct. d. the quantity demanded for the market will increase to less than 30,000 workers.

maximum total demand for labor = 30 (at $8) x 1,000 firms = 30,000 workers, but since the equilibrium rate had been $9 for many years, some workers have already been hired at $9, and it is usually very difficult to lower someone's wage once they have been working. Even thought the quantity demanded will increase, it will probably not be able to reach 30,000 workers.

Assume the following: (1) the interest rate on 6-month treasury bills is 8 percent per annum in the United Kingdom and 4 percent per annum in the United States; (2) today's spot price of the pound is $1.50 while the 6-month forward price of the pound is $1.485.If the price of the 6-month forward pound were to ____, U.S. investors would no longer earn an extra return by shifting funds to the United Kingdom.a. Rise to $1.52b. Rise to $1.53c. Fall to $1.48d. Fall to $1.47

Answers

Answer:

d. Fall to $1.47

Explanation:

currently you will need $1,500 to purchase £1,000 and invest in British bonds. After 65 months you will have £1,040, which you should be able to convert into $1,544.40. If you invested in US bonds, you would have $1,530, so this arbitrage will yield $14.40.

But if instead the British pound fell to $1.47, then your profit would only be $28.80, less than if you invested in US bonds. You again would have £1,040 in 6 months, but that would only be equal to $1,528.80.

The discount rate assigned to an individual project should be based on: Group of answer choices the firm's weighted average cost of capital. the actual sources of funding used for the project. the current risk level of the overall firm. the actual sources of funding used for the project. the estimated riskiness associated with the individual project.

Answers

Answer:

none of the choices are correct

Explanation:

When the discount rate assigned for an individual project then it should be based on the risk i.e attached to the fund use needed by the project

There were various cases when a risky firm invested in a less risky project also if the same cost of capital is used so the firm could alter the decision of an investment in a negative manner

Therefore none of the choices are correct

Exercise 7-4 Direct write-off method LO P1 Dexter Company applies the direct write-off method in accounting for uncollectible accounts. March 11 Dexter determines that it cannot collect $45,000 of its accounts receivable from its customer Leer Company. 29 Leer Company unexpectedly pays its account in full to Dexter Company. Dexter records its recovery of this bad debt. Prepare journal entries to record the above selected transactions of Dexter.

Answers

Answer:

Date            Account Titles and Explanation        Debit          Credit

March 11       Bad debt Expenses                             $45,000

                          Account Receivables                                       $45,000

                    (To record uncollectible accounts receivables)

Date            Account Titles and Explanation        Debit          Credit

March 29    Account Receivables                         $45,000

                         Bad debt Expenses                                          $45,000

                    (To record reversal of written off accounts receivables)

Date            Account Titles and Explanation       Debit          Credit

March 29     Cash                                                  $45,000

                             Accounts Receivables                               $45,000

                     (To record receipt of cash from customers)

InSeason Inc. started a chain of organic supermarkets that had initial success. The managers achieved a mastery of the firm's current environment, thereby filling a need in the market. However, InSeason defined and measured it success by financial metrics, with a focus on short-term performance. As a result, the firm put in place metrics and systems to accommodate and manage increasing firm size due to continued success. As a result of this tightly coupled system, InSeason developed a

Answers

Answer: resistance to change

Explanation:

From the question, we are informed that InSeason Inc. started a chain of organic supermarkets that had initial success and that the managers achieved a mastery of the firm's current environment, thereby filling a need in the market.

We are further told that InSeason defined and measured it success by financial metrics, with a focus on short-term performance and that as a result, the firm put in place metrics and systems to accommodate and manage increasing firm size due to continued success.

As a result of this tightly coupled system, InSeason developed a resistance to change. Resistance to change could be as a result of fear of failure by the company.

grouper Company has an old factory machine that cost $50,750. The machine has accumulated depreciation of $28,420. Grouper has decided to sell the machine. (Credit account titles are automatically indented when amount is entered. Do not indent manually. If no entry is required, select "No Entry" for the account titles and enter 0 for the amounts.) (a) What entry would Grouper make to record the sale of the machine for $25,375 cash

Answers

Answer:

Accumulated depreciation $28,420 (debit)

Cash $25,375 (debit)

Profit and Loss $3,045 (credit)

Cost $50,750 (credit)

Explanation:

For any sale of an Item of Property, Plant and Equipment, the sale must be  accounted as follows :

De-recognize the Accumulated depreciation on the AssetDe-recognize the Cost of the AssetRecognize the Proceeds of the SaleRecognize the Profit or Loss on Sale of the asset (In this case there was a profit)

ristan conducts service and installation visits for a cable company. He uses an online system to access a client's history and updates the system with results from all interactions. This is an example of using _______ to be responsive and build loyalty. business-level strategy process reengineering customer relationship management self-managed work teams total quality management

Answers

Answer: customer relationship management

Explanation:

Customer relationship management has to do with the way organizations relate with their customers in order to meet their needs and satisfy them better.

From the question, we are informed that the worker uses the customer relationship management to access a client's history and updates the system with results from all interactions.

On January​ 1, 2018, Benbrook Company purchased equipment and signed a​ six-year mortgage note for​ $160,000 at​ 15%. The note will be paid in equal annual installments of​ $42,278, beginning January​ 1, 2019. Calculate the balance of Mortgage Payable after the payment of the first installment.​ (Round your answer to the nearest whole​ number.)

Answers

Answer:Balance of the mortgage payable after first installment =  $142,000

Explanation:

Interest Expense of First Installment = Principal x Interest Rate

               = $160,000 X 15% = $24,000

Principle amount of the installment=Total annual  installment−Interest of the first  installment

                =$42,278 −$24,000  =$18,278

Balance of the mortgage payable=   Opening mortgage payable balance

−Principle amount of the first installment

​=$160,000 - $18,278

=$141,722  rounded up to $142,000

When Brandon decided he needed a new car, he immediately called his old college roommate, who owns a BMW dealership, to ask questions about options and financing. Brandon was searching for information from Group of answer choices

Answers

Answer:

external source

Explanation:

In this specific scenario, Brandon was searching for information from an external source. In this case, Brandon's friend is the external source of information, because he is someone from the outside that is capable of providing Brandon with the information that he needs and why Brandon reached out for that information. Internal Information would be information that comes from Brandon's own memories.

Businesses in a country are listed by​ size: small,​ medium, and large. Explain why business size is an example of an​ ordinal-scaled variable.

Answers

Answer:

The business-size contain values that may be used as a rank or order of a categorical variable.

Explanation:

Business size is an example of an ordinal scaled variable because it has a value that is used to rank the categorical variables. However, the variable size in the business is used to categorizing the business in small, medium, and large forms. moreover, the ordinal scaled variable exhibits the variables where the order matters but the difference between orders does not matters. That is why business size is an ordinal scaled variable.

A homeowner decides to rent a spare bedroom in her single-family house to a tenant for $500 per month. When a 24-year-old man asks to see the room, the homeowner refuses, telling him that she will only rent to women over the age of 50. The prospective tenant threatens to sue for a violation of the Fair Housing Act on the basis of age. Should the homeowner be concerned

Answers

Answer:

Should not be concerned

Explanation:

In the scenario being described, it can be said that the homeowner should not be concerned. That is because even though she did discriminate against the individual, Single-family homes rented without the use of a real estate agent or advertising are exempt from the federal Fair Housing Act. This holds true as long as the owner of the property does not own more than three homes at any given time. Therefore since there was no real estate agent, the man can't sue.

An accounting firm conducts periodic reviews of the distribution of pay and other rewards granted to employees, such as promotions and increased office space. The goal of the reviews is to confirm that employees who received greater pay increases or other favorable outcomes have made significant contributions to the organization. This ensures the company uses _______ when rewarding its employees.

Answers

Answer:

distributive justice

Explanation:

Distributive justice refers to the equitable distribution of resources among the different community members. Here, the total amount or any other thing could be fairly allocated to each employee or a member so that the bias could not be existed

Here in the given situation, the employee who made significant contribution to the organization in return they got their pay increased or other beneficial results

So this represents the distributive justice

Cash sales are normally 25% of total sales and all credit sales are expected to be collected in the month following the date of sale. The total amount of cash expected to be received from customers in September is:

Answers

Answer:

The total amount of cash expected to be received from customers in September is the sum of 25% of the September sales plus 75% of the August sales.

Explanation:

What can you tell me about Google's Supply Chain Management ?(10 Marks)

Answers

Answer:

The answer is below

Explanation:

With suppliers across over 60 countries all around the globe, Google continues to organize its supply chain quite efficiently.

Hence, Google’s supply chain management can be summarized in the following key points:

1. Getting reliable suppliers: Google ensures they work with trustworthy suppliers by conducting robust appraisal based on a variety of factors, such as country-specific risk, product-specific risk, suppliers' past records, supplier relationships, etc.

2. Suppliers code of conducting business: this involves social and environmental responsibility and as well as safe working conditions for suppliers' employees.

3. Effective Management of Suppliers Diversity: Google identifies and supports all forms of suppliers' community, regardless of countries, gender, age, disability status, or even sexual orientation of the suppliers. This implies that Google keeps respecting and valuing the contribution of every associated with its supply chain in any capacity.

4. Promoting Tools and Techniques to Supports Suppliers: Google prioritizes training and energy conservations, cost reductions, and product enhancement, for its suppliers, which contribute to easy access to clean and renewable energy.

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