FDA Drug Approval Process: How Drugs Are Approved In The U.S

Author: Trinity M Consulting, LLC. | | Categories: Medical Device Consulting Firm , Regulatory Consultants , Regulatory Strategy


The Food and Drug Administration (FDA) drug approval process is a core component of drug discovery in the United States. Whether it’s a cancer drug or other medication, medical treatments in the U.S. have to go through a specific process to make sure they’re safe and effective before being released to the public. The FDA oversees the process from start to finish and even after approval. Only after a thorough analysis by a team of CDER scientists (Center for Drug Evaluation and Research) can new medicines and treatments be approved for sale in the United States. They review each drug closely using an independent team of professionals and scientists who evaluate the safety, efficacy, and labeling of the drug product.

The many steps and multiple stages of the FDA drug approval process can seem daunting at first. In order to better understand the full FDA drug approval process, the experts at Trinity M Consulting, LLC have written down a simplified version of the multiple steps every drug is required to go through before being brought to market.

The Four Phases Of A Drug Approval Process Include:

Pre-clinical, INDA
In the manufacturer’s early phases of drug discovery (pre-clinical research), they synthesize and screen a drug candidate for toxicity in animals before the medicine moves on to human trials. The sponsor files an Investigational New Drug (IND) Application that details specifics such as chemistry, manufacturing, and the initial plans for human testing. This stage focuses on gathering data on the new drug’s effects on the biological system. The FDA reviews the IND to ensure that clinical trials will be safe for humans and that adequate informed consent is included to protect human subjects.

Clinical trials can begin once a secure baseline has been established, and a new drug has passed the safety, toxicity, and efficacy requirements of pre-clinical studies. This series of tests on living humans are meant to carefully record and observe how a new drug could affect real patients. Spanning from several months to multi-year studies, clinical trials gather important data on how exactly a new drug will perform once released to the market.

New Drug Application (NDA) Review
The New Drug Application (NDA) is the formal step the manufacturer takes to ask that the FDA approve their drug for U.S marketing. For an NDA, the company writes and submits an application that includes thousands of pages to the FDA for review and approval. The NDA includes all animal and human data, along with the side effects, dosing, and effectiveness. Any missing or incomplete data can lead to an immediate refusal and require starting over at the beginning of the process. Once an NDA is filed, the FDA reviews the product label (package insert) to be sure the clinical information needed to safely use this drug is outlined. The FDA also takes action to inspect manufacturing plants where the drug will be made.

Post-marketing Risk Assessments
Once approved and processed, the FDA works with the pharmaceutical industry to monitor and review the new drug. Any concerns or questions involving the new drug are quickly addressed and resolved, sometimes translating into harsh penalties and removal from the market for any unintended side effects. The company is also required to submit periodic safety updates to the FDA.

What Happens After Final Drug Approval?
After final approval, the drug becomes available for physicians to prescribe. However, drugs may not come to the market immediately because of patent disputes, manufacturing issues, or controlled substance designation from the DEA. Pricing is usually revealed after approval, but the FDA does not consider drug pricing or economics as part of the FDA approval process. This is in contrast with many other countries that do consider the economic impact of new drugs on their society.

For more information on the FDA drug approval process, reach out to Trinity M Consulting, LLC. We are a medical device consulting firm based in Florida, focused on providing exceptional customized services for the Medical Device industry. We take pride in creating a partnership with our clients and delivering excellence. Our experts are experienced professionals in Regulatory Affairs, Medical Writing, and Project Management. Our services are available to clients remotely all over the United States.

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