All categories

2 years ago

If the FDA investigator issues a Form FDA 483 after an inspection, the clinical investigator should:

Social Studies

1 answer:

yKpoI14uk [10]2 years ago

6 0

Answer:

If the FDA investigator issues FDA form 483 after an inspection, the clinical investigator should respond to the form in writing in less than 15 working days.

Explanation:

The grounds for issuing an FDA 483 form are that there must be some violations of the Food Drug and Cosmetic Act found after the investigation done by the investigators.
The management of the firm needs to clarify its stand in less than 15 days on the findings of the investigation that concluded in saying that there are apparent violations of the FD&C Act.

You might be interested in

Mrs. Orlof teaches two history classes, one in the morning and one in the afternoon. Yesterday she gave the same test to both cl

leva [86]

Answer:

More student may have taken the test in the afternoon than in the morning.

Explanation:

Mrs. Orlof teaches two history classes, one in the morning and one in the afternoon. Yesterday she gave the same test to both classes. Anyone who failed the test must take a retest. Since a greater percentage of students who took the morning test failed the test than students who took the afternoon test, more of Orloff’s morning history students than afternoon history students will have to take the retest. The conclusion above is not necessarily valid because more student may have taken the test in the afternoon than in the morning.

8 0

2 years ago

Read 2 more answers

The positive effects that have been noted when using hypnosis have been explained in a number of ways. one suggestion is that th

Natasha2012 [34]

Ruling out rival hypotheses, Findings consistent with several hypotheses require additional research to eliminate these hypotheses. More five principles of critical thinking are: (1.) Correlation vs. Causation, the fact that two things are associated with each other doesn’t mean that one causes the other. (2.) Replicability, a finding must be capable of being duplicated by independent researchers following the same recipe. (3.) Occam’s Razor, if two hypotheses explain a phenomenon equally well, we should generally select the simpler one. (4.) Falsifiability, claims must be capable of being disproved. (5.) Extraordinary Claims, the more a claim contradicts what we already know, the more persuasive the evidence must be before we should accept it.

3 0

2 years ago

Claudia is researching her speech on the use of hydrogen fuel cells as an energy source. According to your textbook, Claudia sho

Alex

Answer:

Explanation:

In this scenario, the two best pieces of advice for Claudia is that she should make a separate entry for each note and distinguish in her notes between paraphrases and direct quotations. By making separate notes it allows Claudia to divide topics and concentrate all her attention on a single topic/note at a time. Also when including various information it is important to make sure that you separate what is paraphrased and what are direct quotations in order to prevent plagiarism, which is a serious offense.

6 0

2 years ago

Let's face it—it takes a while to figure out that swift's pulling our leg. When does the proposal cross the line into ludicrous

sertanlavr [38]

Jonathan Swift's Modest Proposal crosses the line into ludicrous territory when he suggests that Irish children should become delicacies for their English Lords.

<h3>What are the main points of Jonathan Swift's Modest Proposal?</h3>

The main points of Jonathan Swift's Modest Proposal included:

The amelioration of poverty in Ireland by butchering Irish children
Selling the butchered children as food to wealthy English landlords
Solving the problem of the homeless youth in Ireland by unconventional means
The offer of cannibalism as a means of solving Ireland's social and political ills
A mockery of the political opinions and ineffectual remedies proposed by others.

Thus, Jonathan Swift's Modest Proposal crosses the line into ludicrous territory when he suggests that Irish children should become delicacies for their English Lords.

Learn more about A Modest Proposal by Jonathan Swift at brainly.com/question/10121048

#SPJ12

8 0

1 year ago

Early bebop drummer; he played the ride rhythms on a cymbal suspended above the drum set; also known for his "feathering" of the

pochemuha

Answer:

Bop established the primacy of virtuosic solo improvisation. From the measure of the artistry and virtuosity of the solo improvisers.

Explanation: Bebop was a sort of "underground" jazz movement in its early years. Its developers and practitioners met in the after-hours of New York's jazz clubs, experimenting with new harmonic and melodic idioms during jam sessions that would sometimes last until dawn.

-Focused on improvisation and solo virtuosity in individual solos, not melody, but focused on harmonics.

The emergence of bebop melodies or "heads."

Bop tempos were faster than any jazz had ever been. This was not dancing music, and it was never really intended to be popular. It was jazz for the artists themselves and for the true jazz lovers.

6 0

2 years ago