1answer.
Ask question
Login Signup
Ask question
All categories
  • English
  • Mathematics
  • Social Studies
  • Business
  • History
  • Health
  • Geography
  • Biology
  • Physics
  • Chemistry
  • Computers and Technology
  • Arts
  • World Languages
  • Spanish
  • French
  • German
  • Advanced Placement (AP)
  • SAT
  • Medicine
  • Law
  • Engineering
Contact [7]
3 years ago
8

A pharma company is awaiting FDA approval for a new drug. It is their first and their only product. They have nothing else in th

e pipeline. Can you provide an approximate for the beta of the company during the FDA approval process.
Health
1 answer:
Irina18 [472]3 years ago
5 0

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).

You might be interested in
Describe a source of radon that could lead to indoor air pollution.
Anuta_ua [19.1K]

Answer:

RADON GAS

Explanation:

This is the main source of indoor radon. It flows through the air, ground and surface water. It primarily finds it's way through the soil into buildings and into water supplies. Once it escapes from soil, it discharges from emission stacks into the air.

8 0
4 years ago
Why does Bourouiba describe a sneeze cloud as multi-phase? How might the size of a droplet affect how it travels through the air
timama [110]

Answer and Explanation:

1. Bourouiba describes the spiral cloud as multiphasic because that cloud contains a variety of materials, such as air, minerals, droplets of varying sizes and can even contain pathogens.

2. The size of the drop influences your weight and this can influence how easily it can be moved in the air. In general, smaller droplets are lighter. During the impulse given in a cloud of spirals, these gothulas are easily propagated in the air, being propagated more quickly than larger droplets that are heavier and propagate at a slower speed.

3. Based on her research, Bourouiba recognizes the danger that people with respiratory diseases present to the community and to herself and, therefore, she is likely to advise people with this type of health problem to avoid places with a large number of people. people, limit physical contacts, wash hands frequently, do not bring hands to mouth, nose and eyes and always use respiratory masks, avoiding the concealment of particles.

5 0
4 years ago
Jackson, age 65, comes to the doctors office complaining of a sharp pain in the right side of his chest. he says his chest hurts
valkas [14]

The answer 1: The pleurisy

Pleurisy corresponds to the presence of liquid between the two sheets of the pleura, the membrane lining the thoracic cavity and having for goal the protection of the lungs. We speak of purulent pleurisy when the fluid contained in this pleural cavity consists of pus.


Answer 2: Pulmonary auscultation

In healthy subjects, pulmonary auscultation can be used to hear normal breathing sounds called vesicular murmur. It results from the movement of air in the tracheobronchial tree and alveoli. He is gentle, breathing in inspiration; it is more intense but shorter in expiration. There may be variations in vesicular murmur intensity as a function of chest wall thickness (eg decreased vesicular murmur in obese subjects).

In the pathological state, several abnormalities can be found at auscultation:

Inversion of the respiratory rhythm with prolongation of expiratory time (emphysema and asthma)

Changes in the vesicular murmur:

Added noises like rales, and pleural friction.


Answer 3:

The auscultation of the lungs will find suspicious signs, showing the presence of fluid in the pleura: sounds heard on normal auscultation are reduced or inexistent, and it is only in one lung generally. The confirmation is simple enough to perform via a chest x-ray showing the presence of fluid in the pleura.

Besides that, the doctor will look at the location of the pain, and he will look for breathlessness too.

5 0
3 years ago
A person's mental and emotional condition does not affect his overall healt
frosja888 [35]
This is a false statement. If a person suffers from mental conditions such as depression, they may experience worse health. The mind correlates with health more than you might think.
3 0
4 years ago
Read 2 more answers
Which disorder is more common in males than females, and shows up in social behaviors such as lying, theft, violence, aggression
Finger [1]
Which disorder is more common in males than females, and shows up in social behaviors such as lying, theft, violence, aggression, and vandalism? Select one of the options below as your answer:

C.conduct disorder
3 0
3 years ago
Read 2 more answers
Other questions:
  • What does Borg's Scale of Perceived Exertion tell you?
    10·1 answer
  • Why do we have puberty?
    8·2 answers
  • Which age is known for an attitude of intellect and reason?
    10·2 answers
  • Pathogens are disease-causing agents. true or false
    10·2 answers
  • Which is not a risk associated with taking illegal steroids?
    15·2 answers
  • According to the unit, which of the following is one of the first steps in meal planning?
    9·2 answers
  • 2. The following are common sports injuries. Which of them is a tear of
    15·2 answers
  • What is Heroin produced from?
    13·1 answer
  • What determines whether a tissue is diseased?
    10·1 answer
  • What examples of an infection and what are non examples of an infection?
    14·1 answer
Add answer
Login
Not registered? Fast signup
Signup
Login Signup
Ask question!