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FDA’s Process for Drug Approval

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The FDA’s objective is to ensure that all drugs designed for medical use are safe and categorized appropriately. The path in which a drug takes before it can be placed on the market is quite long and some don’t make it all the way through. Some drugs get thrown off course as a new discovery for its use is found.

Most drugs first go through preclinical testing on animals and never it makes it to human testing or review by the FDA due to its results.  Those drugs that do make it to FDA review will undergo the agency’s rigorous evaluation process, carefully examining everything about the drug, starting with the clinical trials, the severity of side effects along to the conditions which the drug is manufactured.

Stages of Drug Development and Review

Step One:  Preclinical Testing and Investigational New Drug Application (IND)

Companies, research institutions, and other organizations in the pharmaceutical industry must first preform preclinical (animal) testing on the drug they are developing. Information and results of preclinical testing in laboratory animals and what they propose to do for human testing must be submitted to the FDA through an Investigation New Drug Application (IND). After careful review, the FDA then decides if the drug is safe for the company to begin testing the drug in humans.

Step Two: Clinical Trials

Once an IND is reviewed by the FDA and a local institutional review board (IRB) the company can begin drug studies on humans. Clinicl research is overseen by a board consisting of scientists and non-scientists in hospitals and research institutions.

The clinical trial protocols are then determined by the IRB, which described the type of people who may participate in the clinical trial, the schedule of tests and procedures, the medications and dosages to be studied, the length of the study, the study’s objectives, as well as other details associated with the drugs clinical trial. The IRB insures that all steps are taken to ensure the safety of those participating in the clinical trial and that they are fully aware of the risks associated with it.

Step Three: Phase 1 Testing

The phase 1 testing process is conducted with healthy participants, ranging from 20 to 80 people. The objective of phase 1 testing it to determine what the drug’s most frequent side effects are and, often, how the drug is metabolized and excreted.

Step Four: Phase 2 Testing

As long as phase 1 testing does not show unacceptable toxicity, the phase 2 testing process will be cleared to begin. Participants who have a certain disease or condition, ranging from one dozen to 300 people, will be used during this phase of testing to determine if the drug is effective in treatment. Specific participants will receive the drug in testing and compared with similar participents receiving placebo. Short term effects of the drug are carefully monitored and all steps are taken to ensure the safety of all participants during phase 2 testing.

Step Five: Phase 3 Testing

Phase 3 testing is a large scale study that is determined off the results from phase 1 and 2 by both the FDA and sponsors. The 3rd phase will begin as long as there is evidence that the medication is effective in treatment, various populations have been studied with its use, different dosages are used, and the drug has been used in combination with other drugs. The number of participants during phase 3 testing of a drug will include several hundred to 3,000 people.

Step Six: Review Meeting

After the FDA has approved the drug  for marketing, a postmarket is required as well as commitment studies to be agreed upon to by a sponsors. This will allow the FDA to gather additional information about a product’s safety, efficacy, or optimal use.

Step Seven: NDA

Th sponsors must take the the formal step to ask that the FDA consider approving a new drug for marketing in the United States through a New Drug Application (NDA). This will include all animal and human data and analyses of the data, along with information about how the drug reacts in the body and its manufacturing process.

Step Eight: Application Review

THe FDA has 60 days to decide whether to file the NDA for review once it has been formally submitted. If the application is incomplete the FDA and reject filing the NDA. After the 60 days prior to review it can take up to 10 months for a full review of standard drugs and 6 months for priority drugs.


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