What does ANDA stand for in the context of drug applications?

The term ANDA stands for Abbreviated New Drug Application. This type of application is essential in the drug approval process for generic medications. An ANDA is submitted to the FDA to obtain approval for a new generic version of an already approved brand-name drug.

The significance of the ANDA lies in its streamlined process, allowing manufacturers to demonstrate that their generic product is bioequivalent to the reference listed drug, without the need to conduct large-scale clinical trials again. This regulatory pathway helps promote market competition and can lead to lower drug prices for consumers.

In contrast, the other choices reflect different concepts in drug application processes. Application for New Drug Approval refers to the full application required for new, innovative drugs that have not previously been approved. Annual New Drug Approval is not a recognized term in the regulatory framework. Advanced New Drug Application does not exist as a specific term for the regulatory process. The focus of the ANDA process specifically on generics is critical for efficient drug market access and public health.