Anthony Harrelson - FDA Regulation

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Anthony Harrelson FDA Regulation
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Phase One
As the owner of a pharmaceutical company, Anthony
Harrelson has to develop a drug that will hold up
to the scrutiny of the FDA. This is no easy task,
as the government body takes its task of
regulating drugs for human use very seriously.
The first step that a company must take when
seeking approval for a drug, is to start with
preliminary animal testing to see if it is even
safe enough to graduate to human testing.
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Phase Two
Anthony Harrelson has been working on two new
drugs to help with the treatment of HIV and
Ebola, but first must hold up to the scrutiny of
the FDA. If the drug holds up to the initial
testing on an animal subject, it is then moved
towards clinical trials for humans. These trials
have a three-tiered phase that will determine how
safe and effective the drug is for people. The
FDA watches and determines when the drug can
advance to the next stage.
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Phase Three
Anthony Harrelson is developing new drugs, which
means that he has to get them reviewed by the
FDA. After passing animal and human trials, the
company must send all the data from these tests
to the FDAs Center for Drug Evaluation and
Research. There a team of toxicologists,
pharmacologists, chemists, and other scientists
review the data for accuracy and dictate how it
will be labeled. If the review establishes that
the benefits outweigh risks, it will be approved
for sale.
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Phase Four
Anthony Harrelson is developing a new drug that
he hopes will be entering the marketplace soon.
However, even after the FDA approves a drug for
distribution, it still monitors its performance
and side-effects for a duration of time. This is
to ensure that there are no long-term bad effects
that could have been missed in the approval
process. If a risk is detected here, the FDA
reserves the right to pull the drug off of the
market.
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