The FDA’s Quality Program

January 4, 2021

With Coronavirus Disease 2019 (Covid-19) and potential vaccines dominating the headlines it might be an appropriate time to review the FDA’s Quality Program which is more commonly known as U.S. Food and DrugAdministration Drug Approval Process.

This approval process is performed by the FDA’s Center for Drug Evaluation and Research (CDER). CDER is responsible for evaluating new drugs intended for human use before they can be sold. The center’s evaluation not only prevents quackery but also provides doctors and patients the information they need to use medicines wisely. CDER ensures that drugs, both brand name and generic, are effective and their health benefits outweigh their known risks.

The drug approval process consists of the following steps:

Pre-clinical

Drug Sponsor’s Discovery and Screening Phase

Drug Developed 

The drug sponsor develops a new drug compound and seeks to have it approved by FDA for sale in the United States.

Animals Tested

The drug sponsor must test new drug on animals for toxicity. Multiple species are used to gather basic information on the safety and efficacy of the compound being investigated/ researched.

IND Application 

The drug sponsor submits an Investigational New Drug (IND) application to FDA based on the results from the initial testing that include the drug’s composition and manufacturing, and develops a plan for testing the drug on humans.

IND Review 

FDA reviews the IND to assure that the proposed studies, generally referred to as clinical trials, do not place human subjects at unreasonable risk of harm. FDA also verifies that there are adequate informed consent and human subject protection.

Clinical –Drug Sponsor’s Clinical Studies/Trials

Phase 1 

This phase emphasizes safety. The goal is to determine what the drug’s most frequent side effects are and how the drug is metabolized and excreted. (Typically 20 –80 healthy volunteers.)

Phase 2

This phase emphasizes effectiveness. The goal is to obtain preliminary data on whether the drug works in people who have a certain disease or condition. For Phase 2 trials, patients receiving the drug are compared with similar patients receiving a different treatment –usually a placebo or a different drug. Safety continues to be evaluated and short-term side effects are studied. (Typically a few dozen to about 300 people).

Review Meeting 

At the end of Phase 2, the FDA and the drug sponsor discuss how large-scale studies in Phase 3will be done.

Phase 3 

These studies gather more information about safety and effectiveness, study different populations and different dosages, and uses the drug in combination with other drugs. (Typically, several hundred to about 3,000people).

Review Meeting

FDA meets with the drug sponsor prior to submission of a New Drug Application.

NDA Application 

The drug sponsor formally asks FDA to approve drug for marketing in the United States by submitting a New Drug Application (NDA). An NDA includes all animal and human data and analyses of the data as well as information about how the drug behaves in the body and how it is manufactured.

Application Reviewed 

After the NDA is received, FDA has 60 days to decide whether to file it so it can be reviewed. If FDA files the NDA, the FDA Review Team is assigned to evaluate the sponsor’s research on the drug’s safety and effectiveness.

Drug Labeling 

FDA reviews the drug’s labeling and assures appropriate information is communicated to healthcare professionals and consumers.Facility Inspection –FDA inspects the facilities where the drug will be manufactured.

Drug Approval 

FDA reviewers will approve the application or issue a response letter.Hopefully, having some awareness of the FDAs stringent safety and quality program that must be followed to get anew vaccine to market provides some small amount of comfort in these very uncomfortable times.

COVID-19 Vaccine Development Summary Taken from the FDA’s Drug Approval Process Infographic available on the FDA website.