Understanding The Seven Stages Of FDA’s Drug Review Process

Updated on November 21, 2020

The process that medication has to go through from a laboratory to your medicine cabinet takes a long time, and each medicine takes a unique route each time. In most cases, manufacturers develop a drug to treat a particular disease. But there are also cases where a drug can get discovered through an accident.

For instance, scientists first discovered Retrovir back in the 1960s as a treatment for cancer. However, the results were quite disappointing until researchers found that the drug could help treat AIDs twenty years later.

Experts say that most drugs that underwent preclinical testing never reach human testing and review by the FDA. That’s because these drugs undergo the agency’s meticulous evaluation rule, which carefully examines everything about the drug. Here are the seven stages of drug development and review and how they differ to understand it better.

Stage 1: Animal tested

It’s only standard for most drugs to undergo preclinical or animal testing before proceeding with the application process. It’s where the drugs get tested on animals for any potential side effects before it undergoes human testing.

Stage 2: IND application

There are times when the pharmaceutical industry seeks advice from the FDA before submitting the form for an Investigational New Drug Application (IND).

Stage 3: Phase One testing

Phase 1 testing usually involves healthy volunteers determining the drug’s most common side effects and how often it appears. It’s also the time to determine how the body metabolizes the drug and how it gets excreted. The number of volunteers usually ranges from 20 to 80. It’s also the time when kinase panel screening or test takes place.

Stage 4: Phase Two testing

Phase 2 only starts if the previous studies failed to reveal the drug’s unacceptable toxicity. While the focus in the Phase One trial is on safety, the emphasis in Phase Two is on the drug’s efficacy. Experts consider a drug as effective if it has the effects it purports or stages to be under the same conditions as prescribed.

Meanwhile, for controlled trials, the participants receiving the medication gets compared to other similar patients receiving a different medicine. The tests often either involve a placebo or a different drug. Usually, the number of participants can get as high as 300 individuals.

Stage 5: Phase 3 Testing

Phase 3 starts as soon as the effectiveness of the drug is apparent in Phase 2. Phase 3 aims to gather more information about the medication’s safety and efficacy. At the end of the second phase, both the sponsors and the FDA agree on how to perform large-scale studies during the third phase. The number of participants for Phase 3 involves up to 3,000 respondents.

Stage 6: Review Meeting

It’s a requirement for the drug to undergo commitment studies and fulfill the postmarket requirement agreed to by a particular sponsor. The procedures will get conducted as soon as the FDA has recommended a product for marketing. The FDA employs postmarket qualification and consignment investigations to find further data about a product’s use and safety.

Stage 7: NDA Application

It’s the formal step that a drug sponsor needs to ask the FDA to consider supporting a particular drug for marketing. It includes all the information gathered from all the tests, including its effects on the human body.

The clinical trials take several years to accomplish to ensure its safety and efficacy. That’s why drug sponsors need to familiarize themselves with each stage to understand the entire process better.

+ posts

Throughout the year, our writers feature fresh, in-depth, and relevant information for our audience of 40,000+ healthcare leaders and professionals. As a healthcare business publication, we cover and cherish our relationship with the entire health care industry including administrators, nurses, physicians, physical therapists, pharmacists, and more. We cover a broad spectrum from hospitals to medical offices to outpatient services to eye surgery centers to university settings. We focus on rehabilitation, nursing homes, home care, hospice as well as men’s health, women’s heath, and pediatrics.