Final answer:
Submissions to the FDA under early food safety evaluation for new non-pesticidal proteins produced by new plant varieties intended for food are known as New Protein Consultations. They are part of the process that ensures the safety and efficacy of genetically modified organisms used for human consumption, similar to the NDA and BLA processes for new drugs and biologics.
Step-by-step explanation:
The submissions to the FDA under the early food safety evaluation guidance of new non-pesticidal proteins produced by new plant varieties intended for food are referred to as New Protein Consultations.
This is part of the regulation process for genetically modified organisms (GMOs) where the genetic makeup of a plant is altered to produce new traits such as disease resistance, enhanced nutritional value, or increased shelf life.
The process involves researchers conducting extensive laboratory and animal testing to collect data on the protein's safety and potential use in humans. If it meets the FDA's safety and effectiveness standards, it can move to the next stages of approval.
As part of ensuring the safety of biological therapeutic agents, such as blood and blood products, vaccines, and tissue-based products, the FDA's Center for Biologics Evaluation and Research (CBER) may require a Biologics License Application (BLA) for new biologics.
This is similar to the New Drug Application (NDA) required for new molecular entities considered as new drugs. Before reaching these stages, an Investigational New Drug (IND) application is submitted, and clinical trials on humans can commence following FDA review.