IND vs. NDA
The road to market for drug product development in the USA is a process with several steps and many acronyms. IND and NDA, in particular, tend to get thrown around and frequently mixed up, but what do they mean and what is the difference between them?
Investigational new drug (IND)
An investigational new drug (IND) application is the first step for any pharmaceutical company on their journey to getting a new drug to market. Submitted to the United States Food and Drug Administration (US FDA), the application is a mandatory requirement to allow clinical investigations on unapproved drugs.
Another function of an IND application is to permit shipment of the unapproved drug across state lines, as only marketed drugs are allowed to be shipped from state to state. In which case, the IND acts as a temporary legal function.
There are two forms of INDs:
- Commercial – businesses filing for marketing approval for a new drug
- Research – businesses filing for investigator IND, emergency use IND, and treatment IND, whereby no standard treatment is available and insufficient time exists to receive approval
The IND application must contain information such as:
- Preclinical data to ensure safety in human testing
- Manufacturing information such as the controls used for producing the drug substance and product
- Clinical protocols to evaluate whether the initial-phase trials pose any unnecessary risks to research subjects
- Investigator information to evaluate the qualifications of the clinical professionals who are overseeing the trials
Once submitted to the FDA, the process will take up to 30 days, after which a drug manufacturer may send the drug to the investigators identified in the application.
Download our submission checklist
Now that you are clear on the differences between IND and NDA, head to our step-by-step checklist to find out how to prepare your IND application as the first stage to getting your new drug successfully to market.Download now
New drug application (NDA)
After your IND application has been approved and the clinical trials have been completed, a formal request to market the drug must be made in the form of a new drug application (NDA). This application will include all clinical trial data that has been collected through the completed phases carried out following acceptance of the IND.
This is the final step in a pharmaceutical company’s journey to getting their drug to market. Considerably more complex than an IND, this submission will need to encompass a lot more data (15 sections worth) including: pharmacokinetic and pharmacodynamic data, ingredient information, clinical results, and quality control.
The goal in providing this data is to assure the FDA that:
- The benefits of the new drug outweigh the negatives; safeguarding the effectiveness of the drug
- The intended labeling for the drug is correct and appropriate
- The manufacturing process is suitable to preserve the strength and dosage of the drug
Once submitted, the FDA takes 60 days to decide if it will be filed for further review.
The difference between IND and NDA
As you can see in the figure shown above, the drug development timeline is a complex process. It starts with an IND submission (after the pre-clinical activities are settled to gain approval to cross state lines and start clinical trials) and ends with the NDA submission to ensure all aspects of the drug are effective and ready to market in the USA.
Both applications are essential in acquiring market approval and therefore, it is a high priority for life science companies to complete it in a quick and compliant way.
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