How to Get a Drug Approved by the FDA

Americans top the list of consuming the safest and the most effective drugs, thanks to the pharmaceutical watchdog, FDA.

The Food and Drug Administration plays an important role in protecting the public health of the people.

It does so by ensuring that the drugs: veterinary drugs, biological products, medical devices and cosmetics and products that emit radiation are safe, and secure for use.

FDA also regulates the manufacturing and the marketing process of tobacco and its products.

Nothing is left to chance when into comes to drugs going into the mass market.

The FDA should approve any drug intended to be used by humans.

If the drug gets approved by the FDA, it means that it is safe and effective for use.

Whenever a new drug is developed, it should be approved by the FDA before it is legally released into the market.

All FDA-approved drugs are labeled.

Any company that develops a new drug should follow the process below to have their drugs approved by the FDA.

1.Pre-clinical research and test

Before the company submits its drug to the FDA for sampling, it should conduct rigorous testing on the drug.

The first phase of testing is performed on animals and not humans.

Here, the trial is majorly to determine whether or not the drug will be safe for human consumption.

The company monitors how the animals react to the drug.

Animal testing for the drug can take three years.

When the drug is submitted for sampling to FDA, evidence that the drug underwent this stage will be required.

After undergoing this phase, and after determining that the toxicity levels of the drugs are minimal or negligent, the drug proceeds to the next level.

2.Clinical research

This stage is also conducted by the company that wants their drugs approved to the shelves.

This stage involves testing the drug on human beings.

The primary purpose of this stage is to determine how the drug will react to the human body.

It is one of the most involving stages.

Clinical research should have four phases:

Phase 1:This phase involves testing the drug on between 20 and 100 people.

This stage lasts for several months.

The main purpose of this phase is to determine the dosage of the drug as well as its safety.

Phase 2: Most of the drugs successfully pass the Phase 1.

The drug is tested on several hundreds of people.

The people here must have the disease the drug is intended to treat.

This phase often lasts between two months and two years.

The main purpose of this phase is to monitor the efficacy of the drug, as well as discover the side effects the drug will have on human beings.

Approximately 30% of drugs tested move to phase 3.

Phase 3: Phase 3 involves testing the drug on 300 to 3000 volunteers.

This phase can last for 4 years.

The purpose of this phase is to continue to monitor the efficacy of the drug.

Furthermore, this stage is used to research on the long-term reactions the body could have after using this drug.Around 30% of the drug proceeds to the final phase of clinical research.

Phase 4: Several thousands of volunteers with the target disease are involved in this phase.

This phase is dedicated to monitoring the safety and the efficacy of the drug.

If the drug successfully passes this phase, it qualifies to go for reviews to the FDA.

3.FDA personnel work on evaluating the safety and efficiency of the drug

After a company conducts extensive research on its drug, they submit their drug and a report to FDA.

The drug only gets to this stage after successfully going through pre-clinical and clinical research and tests.

The report submitted to FDA contains the safety details, labeling information, directions for use, pre-clinical and clinical results, and drug abuse potential.

FDA appoints a group of pharmacists, physicians, chemists, statisticians and other scientists to work on the drug.

The team reviews the report to ensure that each application is complete and satisfactory.

The clinical research results are reviewed and tested.

The report submitted to the FDA is often tens of thousands of pages.

If FDA reen lights’ the drug, it means that FDA and the company have approved the drug to move to the next phase of approval.

Besides, FDA and the company collaborate on coming up with prescription information on the approved drug.

After the prescription is developed, FDA labels the drug and legalizes it for sale.

This process may take up to around 12 years, and requires substantial financing.

This is, however, not the end of the approval process.

4.FDA post-market survey

There are a lot of issues that arise from using a drug after it has been released to the market.

For this reason, research continues while the drug is already on the market.

FDA also monitors the manufacturing and marketing of the approved drugs.

This is important for it ensures that the company manufactures and markets its drugs in compliance with the set regulations.

If the company seeks to change anything concerning the drug, it has to apply to FDA.

If the drug gets through the approval process, it means that FDA has evaluated the drug, and concluded that it is safe, and effective for treating a condition it is intended for.

Besides, it means that the health benefits of the drug outweigh the risks the drug posses to its intended consumers.

In conclusion, FDA’s primary job is to evaluate new drugs before they are released to the market.

If the drugs are found to be safe, and effective for human consumption, it will be approved.

If they are unsafe, or if their efficiency can be doubted, they will be rejected by FDA.

If a company develops new drugs, they would have to go through the process discussed above to legally have their drugs released into the drug market.

After the drug has been approved and released to the market, FDA may continue to investigate its efficiency, and potential risk the drug poses to human beings.

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