What is the first application required to be submitted to the FDA before a drug can be tested on humans?

The first application that must be submitted to the FDA before a drug can be tested on humans is the Investigational New Drug Application (IND). This application serves as a critical step in the drug development process, allowing the sponsor (usually a pharmaceutical company) to request permission to start clinical trials in humans.

An IND must include data from preclinical studies, manufacturing information, and a proposed clinical trial protocol. This detailed information is necessary to ensure that the FDA can assess the drug's safety and efficacy before human trials begin. The IND facilitates the monitoring of the drug's progress through clinical phases while ensuring that trial participants are protected.

In contrast, a New Drug Application (NDA) is submitted after successful clinical trials to seek approval for marketing the drug. The Abbreviated New Drug Application (ANDA) is specifically for generics and follows a different regulatory pathway. A Clinical Study Application (CSA) may be relevant in other jurisdictions but does not pertain to the initial FDA requirements for testing new drugs in humans.

Therefore, the IND is essential in the drug development timeline, ensuring that the investigational product meets safety and ethical standards before any human testing can commence.