It’s common knowledge that when a pharmaceutical company would like to market a new drug product in the United States, they must file the drug with the Food & Drug Administration (FDA). But did you know that there are different types of filings depending on what the drug is and where it’s at in its development lifecycle? Read on to learn more!
Federal regulations require sponsors to submit an IND application for an investigational new drug to be used in a clinical investigation. The investigational drug cannot be shipped to the investigator or administered to human subjects until the IND goes into effect.
Examples: Pipeline compounds
This type of filing is specifically for seeking approval of generic drug products. An ANDA is shorter than a normal NDA because preclinical and clinical data are not needed. The application simply needs to prove that the product is bioequivalent (has the same performance as the innovator drug).
Examples: Generic drug products
Once a novel drug shows that it is safe and efficacious in clinical trials, the company files a New Drug Application with the FDA. This filing type is what is needed for official market approval in the United States for small molecule drugs. This extensive application contains the information gathered during the clinical investigation phases under the IND.
This filing type is similar to an NDA, as it results in market approval of a novel medication. The difference between an NDA and a BLA is that NDAs are for small molecule products that are manufactured using chemical synthesis; whereas BLAs are used for filing biologic compounds, including monoclonal antibodies and therapeutic proteins from cell lines.
Once an FDA application such as and NDA, ANDA, or BLA is approved, the product can be manufactured and marketed in the United States in accordance with the conditions specified in the application. However, if anything within the application changes, those updates may need to be given to the FDA as a supplement to the initial application. Read below to learn more about the different processes based on the potential impact of the change.
The PAS must be submitted to and approved by the FDA before distribution of the changed drug product.
Examples:
The change requires a submission to the FDA at least 30 days before the changed drug product is distributed.
Examples:
These changes allow for distribution of the updated product to occur when the FDA receives the supplement.
Examples:
No supplement is needed. The applicant needs to describe any minor changes in the next Annual report submitted to the FDA.
Examples:
Disclaimer: The examples provided above are most applicable to NDAs. Stay tuned for future FSFs to learn more about biologics, devices, and EU filing types!
