How New Drugs Are Being Approved Before They Are Sold


It takes a long time for a drug to move from the laboratory to the shelves for use. The federal agency that approves drugs ensures the drugs have more benefits than risks. Not all drugs made in the laboratory make it to the shelves. After testing, some drugs do not pass the approval process. The responsible agency for drug approval in the U.S is the Food and Drug Administration (FDA). There is a process for approving new drugs before they are sold.

Preclinical Testing

Before any drug is ever given to humans, the pharmaceutical company conducts various studies. The pharmaceutical company then conducts animal studies to check how the drug acts biologically. As you make drugs, the aim is to get drugs that act against the diseases. 

During the preclinical testing, you check how the drug acts and whether its biological acts will affect the host. Also, you need to check how safe the drug is. Drugs need to be safe, and in this stage, you check if the drug is toxic to animals before you move the trial to human beings. The safety should outweigh the risks. Preclinical testing is a long process that takes close to 3 ½ years.

Investigational New Drug Application

Once the drugs pass the preclinical testing, the pharmaceutical company requests the FDA for investigational new drug application, and the testing moves from animals to human beings. Within 30 days, the FDA keeps an eye on the investigational new drug application, and if approved, it becomes effective. 

When filing for an investigational new drug application, you need to point out various things, and they include:

  • Results of preclinical testing
  • How and where you will conduct the next study experiments
  • Chemical structure of the drug and its biological activity
  • Any sides effects noted when testing the drugs on animals
  • How the drug was manufactured

Clinical Trials

When the FDA approves the investigational new drug application, the drug enters clinical trials. RIMs software can be used in this phase to request board approval to get the new pharmaceuticals on the market. Clinical trials have three phases:

Phase 1 

This trial is usually done on healthy volunteers. You will conduct the phase 1 trial on 20-80 volunteers. Phase 1 trial tests the drug’s safety profile, including dosage, absorption, distribution, metabolism, excretion, and duration of action. The entire trial will take an average of 1 year.

Phase 2 

You will carry out this trial on patients with the condition you intend to treat with the drug. It will need 100-300 volunteers with medical conditions. The trial will help determine the dosage and effectiveness of the drug. Phase 2 trial takes close to 2 years.

Phase 3

In this phase, you will carry out the trial on 1000-3000 patients in hospitals and clinics. The trial will help determine the drug’s effectiveness and adverse side effects on patients with different ailments and different age ranges. Phase 3 trial takes an average of 3 years.

New Drug Application

Once done with clinical trials, the pharmaceutical company combines all the obtained data from the studies. If the data shows that the drug is safe and effective, they file for a new drug application with the Food and Drug Administration department. The new drug application should contain every detail of the trials’ findings, and it should have at least 100,000 pages. The details of the new drug application include:

  • Animal and human data used in the trials
  • Side effects of the drug
  • Minimum and maximum dosage
  • Effectiveness
  • How the drug moves in the body
  • Manufacturing process

The FDA will take close to 60 days to review the new drug application and decide if it is fit for further review. Once done filling the new drug application, the Food and Drug Administration checks out the package insert on the drugs to ensure it contains the information needed for safe drug usage.

Wrapping Up

When the drug passes all the steps, the FDA approves it, and the drug will be available for usage. However, after approval, the drug does not get to market immediately. It takes some other processes, which include pricing. Even when in use, the drug is constantly being studied, and you will need to gather information from patients using the drugs to check for any further side effects.


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