Reading for 9/24

Three Interesting Things:

1.) I had no idea that the term "Clinical Research" only applied to studies and trials done on humans rather then animals or other test subjects. When grouping them all together you tend to have a broader or less abstract view of what the study actually entails but breaking down the term makes you start to separate the trial in your mind ahead of time.

2.) I think it is interesting that the FDA approves and regulates drug advertising but yet some companies still get away with falsifying their information about a drug when advertising it. There have been a multitude of law suits where patients experience a side affect or undesired outcome due to advertisements lacking certain information. With the most regulatory group approving all of this it is funky that some still slip through the cracks.

3.) I think that when it comes to naming drugs there is a laboratory name and then a manufacturing name. Its basically further splitting up the industry into the science side and the business side. A scientist in the lab has a vast knowledge of the different classes and scales of drugs but a patient does not. This is why the manufacturer gives the drug a name that is easy to remember, pronounce, and not similar to any other drug already on the market.


Three Questions:
1.)  What is the process of getting a protocol approved by all regulatory committees? How long does it take?

2.) Do trials have to have a list of volunteers or candidates before or after the IND?

3.) Once licensing and approval has been completed and the later trials phase is still occurring, what happens if a problem occurs in the regulatory trial? Do they have to start over or so they just put an FDA pause on it?

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