Glossary

FDA application and review terms.

PDUFA date

The date by which the FDA aims to finish reviewing a new drug or biologic application.

GDUFA goal date

The date by which the FDA aims to act on a generic drug application (ANDA).

NDA

New Drug Application, a request to market a new drug in the US.

BLA

Biologics License Application, a request to market a biologic in the US.

sNDA / sBLA

A supplemental application to add a new use, group of patients or form to an already approved product.

ANDA

Abbreviated New Drug Application, a request to market a generic version of an approved drug.

Approval

The FDA allows the product to be marketed in the US.

Tentative approval

The FDA finds the application meets its requirements, but it cannot be finally approved yet, often because of patents or exclusivity. The product cannot be sold in the US until final approval.

Accelerated approval

An approval based on an early measure of benefit; the company may need a confirmatory study to keep it.

CRL

Complete Response Letter, the FDA's letter saying the application cannot be approved in its current form.

Priority Review

A shorter FDA review goal, generally 6 months instead of the standard 10.

Major amendment

A large addition to a pending application; the FDA may extend its review goal date, often by three months.

Boilerplate

The standard "About the company" text repeated at the end of press releases. It is not the news itself.