The Fda Approval Process

Topics: Pharmacology, Clinical research, Pharmaceutical drug Pages: 3 (912 words) Published: May 27, 2013
The FDA Approval Process
One out of every 1000 medicine compounds that go to the lab test will go one to be tested on humans. The FDA has many phases and trials you have to go through to have a drug approved. It can take as long as twelve years to get a drug approved, and millions of dollars. The FDA approval process for drugs is very lengthy and requires significant funds to complete.

The FDA was created by the Federal food, Drug, and Cosmetic Act in 1938. The FDA does not test drugs, but the do a little research on the drugs (Lipsky, Sharp 362-67). Researchers have to enter applications for there new drug that are around 100,000 pages long. These applications can take up to two and half years to be reviewed. It can also take up twelve years for a drug to go from the lab to the shelf (Drugs Internet).

The first thing a company does to get a drug approved is to test the drug on animals (Meyer, Robert J. FDA’s Drug Approval Process). This process takes about three and a half years. The company will then put in a application with the FDA (Drugs Internet). When they test on animals they are testing to figure out the correct dosage. They are also figuring out how often you should take it and any short and long term effects of the new drug (“FDA Approval Process” Internet). After that they use the test data to develop a plan to test the drug on humans (Meyer, Robert J. FDA’s Drug Approval Process).

After the drug application is approved by the FDA; the FDA makes the drug go through four phases of testing on humans. In the first phase the company uses twenty to eighty healthy people to establish the drug’s safety and profile. In this phase they are looking for any effects on humans and any benefits. These volunteers are watched and are separated into groups based on what happens to them during a one year period. They start separating people into groups when they were testing cancer treatment (Drugs Internet).

In the next phase of the process the company...
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