Which of the following statements are required to be demonstrated for an NDA?

• A. Safe and effective
• B. Benefit outweighs risk
• C. Methods/Controls adequate to preserve identity, strength, quality, and purity
• D. All of the above

Answer: (D)

For an NDA, regulators expect three essential elements: evidence that the product is safe and effective for its intended use, a favorable balance of benefits and risks, and robust manufacturing controls that ensure identity, strength, quality, and purity. Safety and effectiveness data demonstrate that the drug works and has an acceptable safety profile. The benefit–risk assessment weighs how the therapeutic benefits compare to potential risks, and it must be favorable for approval. The manufacturing controls—often described in chemistry, manufacturing, and controls (CMC) sections—show that the product can be consistently produced and remains within specified identity, potency, quality, and purity parameters throughout its shelf life. Because all three areas are required to approve an NDA, the best answer is that all of the above apply.