The time it takes for new drugs to be approved takes many years. Let's take a closer look at the process the US Food and Drug Administration (FDA) generally follows to better understand how new potential medicines are evaluated.
The FDA's role is to evaluate data on an investigational drug and determine whether it should be provided to patients. The FDA aims to ensure that drugs work, and that their health benefits outweigh their known risks. It also provides doctors and patients the information they need to use medicines properly.
of drugs that enter clinical
testing are ultimately approved
Scientists discover a new compound with the potential to become a meaningful medicine.
Drug company tests the drug on animals to learn more about its safety and how it works.
Drug company submits an Investigational New Drug (IND) application to the FDA with key information including:
- What the drug is made of and how the company plans to manufacture it
- Results from animal testing
- Plans for testing the drug in humans (clinical trials)
FDA works to ensure proposed clinical trials:
- Do not place participants at extreme risk or harm
- Provide informed consent and protection for participants
Company submits a New Drug Application (NDA), including the results of all trials, as well as manufacturing information, to the FDA.
NDA ACCEPTANCE AND REVIEW
60 days later, the FDA decides if it will accept
the NDA application.
Can the approval process be shortened?
The FDA may be able to approve a drug more quickly if it is for rare or serious diseases. Available options include:
Fast track is a process designed to help shorten the time it takes to develop and review drugs that treat serious conditions and fill an unmet medical need. It allows early and frequent communication between the drug company and the FDA to help resolve questions and issues quickly.
The FDA can speed up the development and review of a drug if evidence from early clinical trials shows that it is a substantial improvement compared with other available treatments. The evidence can include the effect of the drug on serious symptoms, or how it provides life-saving benefits.
A priority review means that the FDA will aim to take action on an NDA within 6 months (compared with 10 months under standard review).
An FDA regulation that allows early approval for drugs that treat serious conditions or address an unmet medical need. Approval may be granted based on a surrogate endpoint — a measure that reasonably predicts how well a drug may work.