A drug manufacturer wants to provide a generic version of a trade-name drug that eliminates all symptoms of an illness. Its laboratory studies show that the pill contains no dangerous chemicals, reduces symptoms of the illness, and has been produced consistently. Also, no deaths have occurred in the trial period. Why would this drug fail FDA approval as a therapeutic equivalent drug?

The drug does not treat the illness.
The vehicle is not safe.
The product has not been consistent during production.
The drug is not safe.

Answers

Answer 1

The drug failed FDA approval test as a therapeutic equivalent drug because this drug is not found to be safe to use. Thus, the correct option is D.

What is FDA drug approval?

FDA approval of a drug means that the data produced on the drug's effects have been reviewed by the CDER, and the drug is determined to provide benefits which outweigh its known and potential risks for the intended population for that disease.

New drugs and biological products for the use of people must be FDA approved before they are marketed in the interstate commerce. This means that a company must demonstrate that the drug or biological product is safe to use and effective for the intended use of people, and that it can manufacture the product to the federal quality standards.

The given drug failed the FDA approval as a therapeutic equivalent drug may be because the active ingredient present in the drug is different from that of the original medicine used for disease treatment.

Therefore, the correct option is D.

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Related Questions

In the early decades of the United States, were most often considered the healers.
physicians, political leaders, religious leaders, nurses

Answers

Answer:

Professional nursing holds a unique place in the American health care system. As members of the largest health care profession, the nation’s 3.1 million nurses work in diverse settings and fields and are frontline providers of health care services. While most nurses work in acute-care settings such as hospitals, nurses’ expertise and skills extend well beyond hospital walls. Working independently and with other health care professionals, nurses promote the health of individuals, families, and communities. Millions of Americans turn to nurses for delivery of primary health care services, health care education. and health advice and counseling. Nurses are critical links in maintaining a cutting-edge health care system.Nursing continues to be an indispensable service to the American public.  

Drag each label to the correct location on the table.
Sort the units based on the measurement system they're used in.
mentum. All rights reserved.
kilometer
milligram
inch kelvin
SI System
C
C
M
Fahrenheit ounce yard
US Customary System
-

Answers

Si system is :kilo miligram kelvin

us system is: Fahrenheit Ounce yard inch.

What is Fahrenheit?Fahrenheit temperature scale, scale based on 32° for the freezing point of water and 212° for the boiling point of water, the interval between the two being divided into 180 equal parts. The 18th-century German physicist Daniel Gabriel Fahrenheit originally took as the zero of his scale the temperature of an equal ice-salt mixture and selected the values of 30° and 90° for the freezing point of water and normal body temperature, respectively; these later were revised to 32° and 96°, but the final scale required an adjustment to 98.6° for the latter value.

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Which statement does not describe a primary function of the cardiovascular system ? Carries oxygen nutrients and hormones to cells in the body . Send messages to the rest of the body. Removes waste products from the blood. Protect the body against disease and infection.

Answers

Answer:

sends message to the rest of the body

Explanation:

The nervous system sends messages throughout the body, not the cardiovascular system

Describe or explain the relationship between acidosis and diabetes mellitus​

Answers

metabolic acidosis

The overproduction of acid in body fluids is a condition known as metabolic acidosis.

        The Causes are

When the body produces too much acid, metabolic acidosis occurs.It can also happen if the kidneys are unable to adequately eliminate acid from the body.Different kinds of metabolic acidosis exist, including:When molecules known as ketone bodies, which are acidic, accumulate due to uncontrolled diabetes, diabetic acidosis (also known as diabetic ketoacidosis and DKA) develops (usually type 1 diabetes).When the body loses too much sodium bicarbonate, as might happen with severe diarrhea, hyperchloremic acidosis results.kidney illness (uremia, distal renal tubular acidosis, or proximal renal tubular acidosis).lactate acidosisby poisoning

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Lance is a terminal cancer patient who has trouble sleeping at night. His doctor gives him a prescription for a drug that will help him relax and sleep. What kind of drug was MOST likely prescribed?

narcotic
opiate
club drug
barbiturate

Answers

Answer:

It is most likely that the drug prescribed to Lance is a barbiturate. Barbiturates are a type of sedative that can help with sleep and relaxation. They are commonly used to treat insomnia and anxiety. They are not considered to be a narcotic or opiate, which are both types of pain medication. They are also not considered to be a club drug, which are drugs often used recreationally at parties or clubs.

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