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How to Get a New Drug Approved

PDA Approved
PDA Approved

Companies that make drugs are always analyzing various compounds trying to find the ones that have the most therapeutic value. There are many steps, millions of dollars, and thousands of man hours spent on trying to get a medicine approved by the FDA. There are many steps to get your product approved before you can sell it on the open market.

Perfection and Preclinical Testing

During the first six or seven years of preclinical testing the synthesis and purification of a drug gets perfected by the manufacturer. Limited animal testing applies as well. Out of thousands of compounds that are tested, only a few will appear to have enough promise to induce a company to file an IND, or Investigational New Drug Application. If the FDA approves the IND and an Institutional Review Board approves them as well, the manufacturer can start the first part of development.


IND Stage


The IND stage has three different phases. During phase I, clinical trials are conducted on healthy individuals to determine if the drug’s basic properties are safe for humans. The drug will remain in phase I for one to two years. When you encounter phase II, efficacy trials start as the drug is given to volunteers of the population. At the conclusion of phase II, the manufacturer meets with the FDA officials to talk about the process of development, and continued human testing. Phase III is usually the most extensive and expensive part when it comes to drug development.


Knowledge Gained


During the three phases of the IND, the manufacturer can get accelerated development and reviews of the drug. Once the third phase is complete, the manufacturer files an NDA, or New Drug Application. This NDA is reviewed for up to two years, bringing the total years of drug development and approval to around nine years. The NDA stage brings collaboration between the FDA and the experts on the advisory committees. A broad range of advice on drug safety, labeling, and effectiveness can be gained.

Marketing and Labeling

Once approved, the product is marketed with FDA regulated labeling. The FDA will also try to gather what safety information it can from adverse events that get reported. Occasionally requests to update labeling may come through.

Changing Requirements

Over time, there has been a tendency for FDA regulations and requirements to multiply and expand. The first stage of trying to get a new drug approved is preclinical testing. During this stage of production, the toxicology information is recorded and the majority of expenses and time is spent. The new drug must have time to be tested on humans and formula must be perfected. Next, the clinical stage of development has three different parts to it.

New Drug Application

At the beginning of this stage, an Investigational New Drug Application is filed. This document is where you put any information that is pertinent to the drug, which you have gotten through prior research. This part of the process can last anywhere from six to 11 years. Medications are tested for safety, dosing, efficacy, and side effects. At the approval stage of the development process, you should have a new drug application turned in. When your product gets put out on the open market, post market surveillance can be helpful. The product is not done being tested once it is approved.

It is not a short process when getting a new drug approved by the FDA. At first, you will be sifting through thousands of possible combinations that get reduced to just a few of the strongest examples. When you have found your chemical combination, the first few years consist of attempting to see if it is lethal to humans and testing it on a few people to search for side effects. The clinical stage is where the majority of the testing and adjustment get made to the product. Once your drug is approved, you can sell it on the open market to your heart’s content.

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