Abbreviated New Drug Application Process

The Abbreviated New Drug Application (ANDA) process is a pathway for generic drug manufacturers to seek approval from regulatory authorities, like the FDA, to market a drug that is similar to an already approved brand-name medication. It allows them to show that their generic version is safe, effective, and equivalent to the original drug, without needing to conduct extensive clinical trials. This process helps increase access to affordable medications by allowing competition in the pharmaceutical market while ensuring that generics meet the same quality standards as their branded counterparts.