5 Steps of FDA Approvals : Pharmaguideline

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5 Steps of FDA Approvals

FDA is the United States Food and Drug Administration, and it is responsible for regulating products that come into contact with the food chain.
Medicines are not food and those are taken by unhealthy individuals. Therefore, the safety and efficacy of the drug product are a primary requirement while producing the medicines. Drug approval by the FDA is a critical process and has to follow different steps before any drug product reaches to the market. The following steps are followed by any company to get approval from the FDA to produce and market any drug product.

Step 1: Discovery and Development

It has two stages discovery and development

1. Discovery

Generally, research scholars discover new drugs to minimize or reverse the effects of disease. These medicines have a negative impact on the drug while they do not have any adverse effect on the body.

Initially, there may be a number of chemicals those are selected for the research but in further stages, some potential chemicals are selected for detailed study The selected compounds are further studied to develop a drug for selected disease.

2. Development

Once a potential compound is selected by the research scholars then it is further studied with different experiments to develop the drug. Generally following studies are done.
  • How the selected compound is absorbed and metabolized by the body
  • It’s mechanism of action and potential benefits
  • Its optimum dose for the disease
  • Mode of administration of the drug
  • Side effects and toxicity of the drug
  • Effect of drug on the different groups of people
  • Interaction of drug with other medicines
  • Comparison of drug with other similar drugs if available

Step 2: Preclinical Research

Research scholars determine the toxicity of the drug before testing it on humans because it can harm people. FDA recommends that research scholars test the drugs in the laboratory using good laboratory practices. Preclinical studies are not done on a large number of people. This study is used to get information about the toxicity of the drug compound and help to decide whether it is safe or not to test the drug on the human population

Step 3: Clinical Research

In clinical research are tested on the human body to find any adverse effects while drugs are taken for a longer period. Clinical trials are done in the following three phases.

Phase 1: Phase 1 clinical trials are done on 20 -100 healthy or people having the disease for several months. The effect of the drug on the disease and the people are studied during this phase. Approximately 70% of drugs pass this phase and move towards the next phase.

Phase 2: In this phase, the drug is tested on hundreds of patients having the disease for a period of several months to two years. Data is collected and compiled after the completion of phase second. 30% of drugs pass this phase and move forward to the next phase.

Phase 3: In this phase, the study is done on 300 to 3000 people having the disease for one year to 4 years. 25 to 30% of drugs pass this phase and move forward to the next phase study.

Phase 4: In phase 4 of the clinical trial, a clinical study is done on thousands of people having disease and data collected is compiled and reviewed to proceed further.

Step 4: FDA Drug Review

After completion of the clinical study and making sure that the drug is safe for human consumption, it is submitted for FDA review and it is called a New Drug Application (NDA). After submitting to the FDA for review, the FDA reviews if the submitted drug application is complete. FDA rejects incomplete applications. It takes 6 to 10 months to review the application and make the decision for approval by the FDA team.

Step 5: FDA Post-Market Drug Safety Monitoring

A drug product passes through several stages before it is sold in the market but it is not possible to check its long-term side effects. So, the product is observed for its efficacy and safety by the FDA. FDA can ban the product from the market if any adverse effect is found during the use of the product. This improves the safety of the consumers from substandard products.

Finding a new drug for any disease is a time-consuming and difficult process. This drug approval process takes time and effort because above mentioned steps and necessary to follow to get any drug approval from the FDA. Feel free to contact us if you need any help in the drug discovery and approval process.
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Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of pharmaguideline.com, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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