What is the difference between nda and 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. 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. 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.

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.

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.

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.

Hence, authoring them with precision should be a high priority for manufacturers who are willing to enter the market in a quick and compliant way. Reach out to Freyr at sales freyrsolutions. You are here Home » Resource Center » What is? Your browser does not support the audio element.

It also includes any previous history of use of the drug on humans. Manufacturing Information — This section contains information that ensures the capability of the manufacturing unit for producing adequate batches of the drug. The Act requires a firm who manufactures a biologic for sale in interstate commerce to hold a license for the product.

A biologics license application is a submission that contains specific information on the manufacturing processes, chemistry, pharmacology, clinical pharmacology and the medical affects of the biologic product. If the information provided meets FDA requirements, the application is approved and a license is issued allowing the firm to market the product.

Important Addresses for Regulatory Submissions. The pages in this section give detailed information about the following types of applications: Investigational New Drug IND Current Federal law requires that a drug be the subject of an approved marketing application before it is transported or distributed across state lines.