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.
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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 pays 100 to 300 patient volunteers (Drugs Internet).
This phase is important because it gathers more information about the drugs effects on a larger group of people, unlike the first phase. Also in this phase you are mostly likely going to find out if the drug fails or not.
This could be because the drug’s side effects are found to be to server to benefit the human. The drug could also be found not to work as planned (“Understanding Clinical Trials” Internet).
This process usually takes up to two years (Drugs Internet).
In phase three of this process 1000 to 3000 patient in clinics or hospitals are watch to ensure the drugs safety. This phase is very important to companies because they test the drug on a various types of patients other then the ones the drug was made for. They also use the information they get from this test for their marketing claims.
This phase is different from other phases because patients in this phase can continue to take the drug before it hits the market if it is a lifesaving treatment (“Understanding Clinical Trials” Internet).
This phase is the longest out of them all; it usually takes about three years (Drugs Internet).
After the third step the company has to file another application with the FDA usually around 100,000 pages long. It usually takes the FDA two and a half years to review the application (Drugs Internet).
In the finally phase is known as the post marketing surveillance procedure phase.
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The company continues to turn in reports about their drug to continue selling it on the market. These reports help them see how the product is doing after a long period of time. These studies are usually required by the authorities who regulate the selling of pharmaceutical drugs. But the can be required by the company of sponsors the drug. The reason for this might because they want to find a new market for the drug (Lipsky, Sharp 362-67).
Presently there are thousands of ongoing clinical trials. These trials involved hundreds of thousands of subjects (Meyer, Robert J.
FDA’s Drug Approval Process).
There are eight primary regulations of the clinical investigator. The first one is to conduct or supervise the study. Secondly they have to conduct the study according to the approved protocol or research plan. Next they have to ensure that the institutional review board (IRB) has study and reviewed it, and approve it. Also they have to make sure it is functioning according to the FDA requirements. Then they have to obtain consent from the FDA. After that they have to maintain adequate and accurate records of study observations.
Next they have to administer the drug only to the subjects under the investigator’s personal supervision. They also have to report everything to the sponsor adverse experiences that occurred during the investigation. Finally they report everything to the IRB including all problems involving risks to humans or others (Meyer, Robert J. FDA’s Drug Approval Process).
The approval process to get a drug approve is very long and you have to use a lot of money to get them approve. Researcher can invest up to 12. 6 billion dollars a year in new drugs. Also this figure usually doubles every five years.
