Biotech companies always share the following with the FDA: A. Exact composition of the drug or device B. Adverse event reports C. Bio-statistical data D. Coding embed in medical devices E. Costs

Answers

Answer 1

Biotech companies always share the following with the FDA: A. Exact composition of the drug or device

A. Exact composition of the drug or device: Companies must provide detailed information on the ingredients and manufacturing process of their product to ensure safety and efficacy.

B. Adverse event reports: Biotech companies are required to report any adverse events or side effects experienced by patients during clinical trials or after product approval. This helps the FDA monitor product safety and take necessary actions if needed.

C. Bio-statistical data: This data includes results from clinical trials and other studies to demonstrate the safety and efficacy of the drug or device. The FDA reviews this information to make informed decisions regarding product approval.

D. Coding embedded in medical devices: Companies must share the software code used in their medical devices to ensure that it functions safely and effectively. This allows the FDA to assess the device's performance and identify any potential vulnerabilities.

E. Costs: While biotech companies do not generally need to share their cost information with the FDA, they may choose to do so voluntarily in some cases, such as when seeking reimbursement or pricing approvals from other government agencies.

In summary, biotech companies share important information with the FDA, such as the exact composition of their product, adverse event reports, bio-statistical data, and coding embedded in medical devices, to ensure the safety and effectiveness of their products.

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Related Questions

As the price of Pufs increased, the demand for Huks has decreased. Based on this information, what type of good is a Huk?

Answers

More than likely a superior good.

someone please help !!

i need to fill the blanks in w descriptions from the bank on the right, based of an article. some descriptions also need to be inferred. (dark grey boxes are not to be answered)

https ://www.allbus ines s .com/advantages-and-dis advantages -of-sole-proprietors hips -3-875-1.html

Answers

Answer:

aph development continues with an expression of the rationale or the explanation that the writer gives for how the reader should interpret the information presented in the idea statement or topic sentence of the paragraph. The writer explains his/her thinking about the main topic, idea, or focus of the paragrap

Explanation:

The blank is the the minimum amount of your bill you must pay each month.

Answers

minimum payment

the least amount of money that must be paid at the end of a month

Productivity is an important goal for Clearwater Electronics. Like most productive organizations, Clearwater recognizes the contributions human resource management (HRM) can make to improve productivity through people. How can HRM best ensure that the work environment at Clearwater is one in which employees are productive and add value?

Answers

Answer:

HR managers can contribute by providing work organization and design that allow for an increase of output as well as quality

Explanation:

Place the steps for proper lifting technique in the correct order. --Select-- --Select-- --Select- --Select-- --Select- --Select-​

Answers

Answer:hold up

Explanation:

On January 1, Salter Corporation determined that its direct materials inventory needs to contain 6,000 pounds of materials by March 31. To achieve this goal, Salter will have to use four pounds of direct materials for every pound that it purchases during the upcoming quarter. On the basis of the company's budgeted sales volume, management estimates that 5,000 pounds of direct materials need to be purchased by March 31. Determine the number of pounds in Salter's beginning direct materials inventory on January 1.

Answers

Answer: 21000

Explanation:

Direct materials inventory desired = 6,000

Purchase of direct materials budgeted = 5000

Pounds needed for production = 5000 × 4 = 20000

The number of pounds in Salter's beginning direct materials inventory on January 1 will be:

= Direct materials inventory desired + Pounds needed for production -

Purchase of direct materials budgeted

= 6000 + 20000 - 5000

= 21000 pounds

ordinary kriging method assume that​

Answers

Ordinary kriging, for which the assumption of stationarity (that the mean and variance of the values is constant across the spatial field) must be assumed.

Sue says that customers are "expecting a whole lot more for their dollars so the level of customer service has to be that much better and the level of our offerings has to match their expectations". Sue decides to send an email survey to current customers to discover what additional services Camp Bow Wow might offer. Based on the results, Sue intends to implement new services. This is an example of: A. Applied research B. Basic research C. Fact finding D. Development and implementation

Answers

Answer:

A. Applied research

Explanation:

Applied research is defined as a study that is aimed at finding answers to specific practical problems. The information.gained from applied research is usually applied to business activity to improve a product, service, or process.

In the given scenario Sue sends an email survey to current customers to discover what additional services Camp Bow Wow might offer. Based on the results, Sue intends to implement new services.

She is using applied research to gain information that will improve customer service in the organisation

Jose wants to find out how many men wear bright colored ties. Which
marketing research tool should he use?

A. Survey
B. Business records
C. Focus group
D. Census data

Answers

Answer:

survey

Explanation:

According to the scenario, a survey is the marketing research tool they used. Thus, option 'A' is the correct option.

What is a survey?

A survey is a set of questions used in human subject research with the goal of gathering specific information from a certain population. Surveys can be carried out via the phone, by mail, online, at street corners, and even in shopping centers. Surveys are used to collect data or learn more in areas like demography and social research. Survey research is frequently used to evaluate ideas, beliefs, and emotions.

Surveys might have narrow, focused objectives or they can have broad, more general objectives. In addition to being utilized to satisfy the more practical requirements of the media, such as evaluating political candidates, public health authorities, professional organizations, and advertising and marketing directors, surveys are frequently employed by psychologists and sociologists to evaluate behavior.

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1. Abler Corporation has corporate bonds trading in the market at $820. These bonds have $1000 face (or maturity) value and pay an 8% stated (or coupon) rate annually ($40 every six months). These bonds have 12 years to maturity. What is the pretax cost of Abler Corporation's debt?

Answers

Answer:

10.70%

Explanation:

NPER = 12*2 = 24

PMT = 40

PV = -820

FV = 1000

Pretax Cost of Debt = Rate (NPER, PMT, -PV, FV) * 2

Pretax Cost of Debt = Rate(24, 40, -820, 1000) * 2

Pretax Cost of Debt = 0.0535 * 2

Pretax Cost of Debt = 5.35% * 2

Pretax Cost of Debt = 10.70%

FINISH THIS SENTANCE
There was this blind man, right? He Was feeling his way down the street with this stick,

Answers

when he runs into a old dog who so happens to be a dog that guides blind people.

At the end of a long day, Sabrina, a cashier for a supermarket is counting the paper money. One of the bills falls from the cash register into the bottom of Sabrina's purse. What elements of embezzlement are present in this situation? Should Sabrina be convicted of embezzlement? Why or why not?

Answers

Answer:

It is an act of theft and conversion of property that is not her own. However it is not intentional

She should not be convicted

Explanation:

Embezzlement is defined as the intentional managemnet of.funda that are put in the care of a person. This is done in order to have a personal gain from the management.

It is when an individual engages in theft of entrusted funds.

In the given scenario although the cash fell into her bag, she did not intentionally take the money for personal gain.

As this is the main concept of embezzlement, she can't be held guilty of embezzlement

Which of the following list of factors of production would be considered land?

O Factories, assembly lines, buildings

O Farms, tractors, pesticides

O Iron ore, natural gas, water

O Dams, bridges, oil wells

Answers

Most likely answer is option 1

HELP ASAP...Just tap the photo to read the problem

Answers

Answer:

Red Dear

Explanation:

Red Dear tell the location of Human Resources

a rectangular swimming pool has dimensions 45 metre by 20 metre concrete path of 3.5 m width is laid around it .Find the cost of laying the path at a rate ₹25 per m2​

Answers

Answer:

Rs. 5993.75

Explanation:

The computation of the cost of laying the path is given below:

= {area of(pool +path)- area of pool }

= ((45 + 3.5) × (20 + 3.5)) - (45 × 20)

= (48.5×23.5) - (45 × 20)

= 1139.75 - 900

= 239.75 square meters

Now the cost is

= 239.75 × 25

= Rs. 5993.75

Select all that apply.
Which of these are true of a natural pause following a conversation?
You should begin speaking to avoid awkwardness.
You should not panic.
Take a moment to collect your thoughts before you speak.
Conversations that end with a pause went poorly.

Answers

Answer: all of the above.

Why? Because all of them are important in a conversation!
speaking to avoid awkwardness is good so you won’t end up ruining the conversation without realizing and giving the other person a bad impression about yourself. And not panicking is quite important too, because when you panic and get negative thoughts you’ll realize that it’s keeping you down and making you feel bad or anxious about every single word you say. And lastly collecting your thoughts and putting them in order (few seconds before starting a conversation) can be helpful to most people which will make them feel more confident and prepare especially if the conversation was serious.

Answer:

You should not panic

AND

Take a moment to collect your thoughts before you speak.

Explanation:

Hope this helps!

Devon, a Project Manager is working on a software development project. He needs more coders to complete the project on time. As a result, he hires people and they are given on-the-job training by their coworkers. However, this significantly reduces the output of th team and leads to a delay in the project. The given scenario exemplifies:

Answers

Answer: the mythical man-month effect

Explanation:

The scenario given in the question above signifies the mythical man-month effect.

According to the mythical man-month effect, it explains that when more programmers are added to a particular project, this eventually led to a delay in the project.

Since we are told that Devon needs more coders to complete the project on time and therefore hired more people to complete the project but eventually led to a delay, thus signifies the mythical man-month effect.

Pizza Hut is an American restaurant chain that offers different styles of pizzas and many other fast food options. There are more than 5,600 store locations in 94 countries around the world, which are owned and operated by the local population of those countries by giving access to patents, trademarks, etc. (a) Which form of international business is adopted by Pizza Hut? Explain. (b) Explain any two advantages and any two disadvantages of this form of international business.

Answers

Answer:

(a) Which form of international business is adopted by Pizza Hut? Explain.

Pizza Hut operates through franchises. Basically Yum (which owns Pizza Hut) is the franchisor that allows the franchisee to invest in a restaurant, operate it and it must pay the franchisor certain fees.

(b) Explain any two advantages and any two disadvantages of this form of international business.

Advantages:

higher rate of success for new businessesprior experience is not required since the franchisor provides training, counseling and a business model.

Disadvantages:

Franchisees must follow the business model and cannot innovatethe risk of poor service offered by some franchisees always exist

Workplace diversity describes differences among workers in any of the following areas:
salary
office space
religion
Orace
select all that apply.

Answers

Answer= religion and race.

Office space and salary are not an example of diversity.

I hope this helps.

HELP PLEASE ILL GIVE CROWN!!!!
the percentage you will need to pay in interest on a loan will NOT depend on what factor?
A. your history of paying back loans in the past.
B. your volunteer activities and proof that you are a good person.
C. your overall credit score.
D. the financial choices you have previously made.

Answers

Answer:

B

Explanation:

This has nothing to do with your financial history, while every other option does.

According to Archbishop John Foley, what three standards does the church set forth for marketers?

Answers

Answer:

One is truth: Always tell the truth. The second one is the dignity of the person, so don't exploit people. And the third principle is the common good  that advertising should serve the common good.

Explanation:

:)

Why is being a flight attendant a good job

Answers

Answer:

cuz ur parents will call u a failure

Explanation:

Answer:

You are able to fly around the world and meet new cultures

Explanation:

How will taxation influence the circular flow model

Answers

Answer:

TMS

Explanation:

Taxes (T) imposed by the government reduced the flow of income.

Money paid to foreign companies for imports (M) also constitutes a leakage.

Savings (S) by businesses that would have been put to use are a decrease in the circular flow of an economy's income.

Describe a situation where value at one level of the enterprise may not be seen as valuable at another level

Answers

Answer:

At the Board level of a traditional company, the value delivered by a company's Information technology unit is rarely mentioned or discussed if they are not an IT firm.

This is attributable to the inability of traditional firm-level economic analysis to bring fully to the fore, in a langugage that the Board of governors can understand, the intangible impacts of IT delivers to the overall business value.

The purchase of faster laptops and better productivity tools (for instance) which help to foster collaboration irrespective of time or space will in some way translate to increased bottom line due to increased effectiveness and efficiency might go unaccounted for or unnoticed in a board level report.

However, the sales-manager who brought in more money in sales will most likely get very decent attention from the powers that be.

Cheers

List of the least five behaviors you feel would be behavior you feel would be considered irresponsible in the workplace. For each behavior listed, provide a detailed example/scenario to detail what makes the behavior either responsible or irresponsible.

Answers

Answer: See Explanation

Explanation:

Some of the behaviors that would be considered irresponsible in the workplace include:

1. Lateness: Every company has its working hours and it is required for the employees to adhere to the working hours and always get to work on time. Lateness is a bad habit in the workplace. For a company to achieve its goals, it's required for its workers to come to their workplace early and perform their duty well.

2. Cyberslackers: This occurs when the employees use the internet that is meant for work related activities to surf the net and browse sites that doesn't relate to their work. For example, a case whereby an employee is checking his or her social media at the workplace.

3. Lying to other employees: It is a bad behavior for an employee to lie or say something that's not true about a person in order to gain an advantage or for other person reasons Lying brings about lack of trust and disunity in the workplace.

4. Having a bad character: In an organization, it is vital for the employees to possess good characters such as being kind, caring, helpful etc. Possessing a bad character will have a negative effect on the company.

5. Theft: Employee theft is also an irresponsible behavior in the workplace. Stealing has a negative effect on the revenue of the company as it reduces the revenue such company makes. Employees should always make sure that they do not falsify information in order to gain a financial advantage or steal company's fund.

1. Describe ways in which individuals you know have developed differently from others .

Answers

Answer:

Key takeaway: Our perceptions are influenced by our individual differences and preconceived notions.

Explanation:

Physical characteristics influence how we perceive and respond to information. You may be asked to design a sign that says, “Watch your head,” which will be placed next to a six foot six inch overhang that is above floor level. While a few very tall people will have to worry about hitting their heads on the overhang, most people in the world are not that tall. Tall and short individuals will perceive this sign differently.

Your psychological state can also influence what you read and listen to, and why you do so. The emergency procedures binder on the wall next to the first aid kit doesn’t mean much to you until a coworker falls and suffers some bad cuts and bruises. If you were asked to design the binder and its contents, could you anticipate a psychological state of anxiety that would likely be present when someone needed the information? If so, then you might use clear bullet lists, concise, declarative sentences, and diagrams to communicate clearly.

Your cultural background plays a significant role in what and how you perceive your world. You may be from a culture that values community. For example, the message across the advertisement reads: Stand out from the crowd. Given your cultural background, it may not be a very effective slogan to get your attention.

Our perceptual set involves our attitudes, beliefs, and values about the world. Perhaps you’ve heard the phrase, “Looking at the world through rose-colored glasses” and can even think of someone as an example. We experience the world through mediated images and mass communication. We also come to know one another interpersonally in groups. All these experiences help form our mental expectations of what is happening and what will happen.

Think about your brand preferences, your choice of transportation, your self-expression through your clothing, haircut, and jewelry—all these external symbols represent in some way how you view yourself within your community and the world. We can extend this perspective in many ways, both positive and negative, and see that understanding the perspective of the audience takes on new levels of importance.

If OSHA's regulations are not obeyed, what can OSHA do
to the people who are responsible? (Select two answers.)
Make them move to a different state.
Fire them.
Fine them.
Take them to court for committing a crime.
Make them create a Web site.

Answers

Answer:

Make them move to a different state.

Fire them.

Answer:

3  & 4

Explanation:

i got it right

Workplace diversity describes differences among workers in any of the following areas:
salary
office space
religion
race
Select all that apply.

Answers

Answer:salary

All

Explanation:

1.2.
State which environment unions are found in.​

Answers

United state maybe cause you said which state ;-;

what are vital events?

Answers

Answer:

efers to the live birth, death, foetal death, marriage, divorce, adoption, legitimation, recognition of parenthood, annulment of marriage, or legal separation.

Explanation:


Description
Vital statistics is accumulated data gathered on live births, deaths, migration, fetal deaths, marriages and divorces. The most common way of collecting information on these events is through civil registration, an administrative system used by governments to record vital events which occur in their populations
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true or false ti1ere are fewer benefits from budgeting in companies with uncertain or complicated environments. Why was the Congo one of the last areas of Africa to be colonized by Europeans? The factor appears in many relativistic expressions. A value =1.01 implies that relativity changes the Newtonian values by approximately 1% and that relativistic effects can no longer be ignored.A. At what kinetic energy, in MeV, is = 1.03 for an electron?B. At what kinetic energy, in MeV, is = 1.03 for a proton? Due to the complaints he hears daily from his sister, Johan already had background knowledge of how most Indians talk. She often rants about how awful Indians' speaking skills are. And that listening to them would lead you to want to take an aspirin. As a result, when he had an urgent meeting with an Indian staff member, he only acted as if he was listening to end the meeting quickly. Which of the following barriers in communication is being implied in the situation Diagram 1 shows the nucleus of a body cell as it begins to divide by mitosisDiagram 1 shows gametes.Complete diagram 2 to show what the nucleus of one of the cells produced by this mitosis would look like What is the answer please Create a router table for Router B. For each row in the table identify the destination network IP Address and the IP Address used for the next hop (do not use the letter name for the routers). Note, the Networks (drawn as clouds) may have multiple routers in them so only select IP addresses directly tied to the routers as shown. Assume all network addresses use a /8 mask and the cost (hop value) for all connections is 1. Router R should be the default next hop. More rows are needed. Which of the following statements about the innate immune response is true?a. Innate immune responses are produced by interactions among several types of white blood cells.b. Innate immune responses represent the first line of defense against invading pathogens.c. The innate immune response depends on the activity of cytotoxic T cells.d. Innate immune responses repel all types of microbes equally. TRUE OR FALSE a principal can ratify an agent's unauthorized contract even if the third party withdrew from the contract prior to ratification. Which of the following statements regarding IPv6 subnetting is NOT accurate?IPv6 addressing uses no classes, and is therefore classless.The largest IPv6 subnet capable of being created is a /64.A single IPv6 subnet is capable of supplying 8,446,744,073,709,551,616 IPv6 addresses.IPv6 does not use subnet masks. Is it possible to convert the dessert into fruit dessert since most of the given ingredients consist of fruit items? Why yes and why not why are people-even when they are affluent-reluctant to move to continuing-care retirement communities?Select one:a. fearing that entering means admitting "I am old"b. believing their families should take totl care of their needsc. wondering about the quality of the servicesd. thinking they will be robbed by the staff in the series circuit shown below, what would happen if one of the light bulbs and its attached wire segment were removed? What is the peak wavelength of light coming from a star with a temperature of 7,750 K?(Submit your answer in nanometers. Remember 1nm = 10-9 m) using the instruction set above if a memory location in the textbook computer has the hexadecimal value 100f what does it mean in a program? Derive a finite difference approximation formula for the second derivative f" x(i) of a function f( xi) at point xi using four points xi-2, xi-1, xi, xi+1 that are not equally spaced. The point spacing is such that xi-1 - xi-2 =h1, xi - xi-1 =h2, and xi+1 - xi = h3. (0)When clicking on a collider within the clock-face, the time is updated using the following steps:Group of answer choicesThe StartTime method is called, and the system clock Euler angle relative to the clockface, is passed onto the Y transform of the hour hand of the clock.Nothing happens. This feature cannot be added.The UpdateTime method is called, and the local Euler angle is passed onto the Y transform of the hour hand of the clock.The UpdateTime method is called, and the local Euler angle is passed onto the X transform of the hour hand of the clock. Chin correctly translated the following phrase into an algebraic expression. ""one-fifth less than the product of seven and a number"" Which expression represents Chins phrase? 7 n one-fifth StartFraction 7 n minus 1 Over 5 EndFraction StartFraction 7 n 1 Over 5 EndFraction 7 n minus one-fifth. which configuration file should you edit to enable pluggable authentication modules (pam) to check for a file named /etc/nologin? After a function's last statement is executed, the program returns to the next line after the___a. function call b. function definition c. import statement d. start of the program