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!
FDA Regulatory Filing Types
FDA Drug Application Types
Investigational New Drug Application (IND)
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
Abbreviated New Drug Application (ANDA)
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
New Drug Application (NDA)
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.
Biologics License Application (BLA)
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.
Making Changes to an Approved FDA Application
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.
Reporting Categories for Changes to an Approved Marketing Application
Major Change:
Prior Approval Supplement (PAS)
The PAS must be submitted to and approved by the FDA before distribution of the changed drug product.
Examples:
- Move to new manufacturing site that doesn’t manufacture similar products
- Change in the primary packaging components (ex. vial, syringe) for a liquid formulation
- Label changes associated with new indications and usage
Moderate Change:
Changes Being Effected in 30 Days (CBE-30)
The change requires a submission to the FDA at least 30 days before the changed drug product is distributed.
Examples:
- Move to a new manufacturing site that manufactures similar products
- Changes in process parameters or equipment
Changes Being Effected (CBE-0)
These changes allow for distribution of the updated product to occur when the FDA receives the supplement.
Examples:
- Eliminating in-process filtration of a terminally sterilized product
Minor Change:
Annual Report
No supplement is needed. The applicant needs to describe any minor changes in the next Annual report submitted to the FDA.
Examples:
- Change in secondary packaging site
- Editorial label changes
- Shelf-life extensions
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!
