Which agency oversees mostly plant GMOs but also animal drugs, and conducts consultations, oversees New Animal Drug Applications (NADA) and New Drug Applications (NDA), as well as regulation of biological products?

• A. NEPA
• B. FDA
• C. APHIS
• D. EPA

Answer: (B)

The key idea is that this agency regulates drugs and biologics and also engages with sponsors during product development. The FDA handles the approval and oversight of animal drugs (through the animal drug approval process known as NADA) and human drugs (the NDA process). It also regulates biological products like vaccines and other biologics, which is managed by its biologics centers. In addition, FDA provides premarket consultations with sponsors, helping to outline what studies and data are needed before submitting an application. While plant GMOs are primarily the domain of another agency (USDA APHIS) for plant health and pest‑risk regulation, FDA’s remit clearly includes animal drugs, human drugs, and regulation of biologics, along with the development consultations that accompany those submissions. That combination makes FDA the best match for this question.