ANDA submitted to CDER must demonstrate

• A. Bioequivalence
• B. Safety and efficacy in new trials
• C. Manufacturing facility inspection not required
• D. No labeling requirements

Answer: (A)

Bioequivalence to the reference product is what an ANDA must show. The goal of an abbreviated new drug application is to prove that the generic will behave in the body the same way as the brand-name product, so patients receive the same safety and efficacy profile without needing new clinical trials.

In practice, this means demonstrating that the rate and extent of active ingredient absorption are essentially the same as the reference. This is usually shown with pharmacokinetic studies that compare parameters like Cmax (peak blood concentration) and AUC (overall exposure). The common standard is that the 90% confidence intervals for the ratio of these parameters (test versus reference) fall within about 80% to 125% for most drugs. Some drugs with high variability or special safety concerns may have adjusted criteria, but the core idea remains matching exposure closely.

Supportive in vitro tests, such as dissolution, can bolster the demonstration for certain products, but the binding requirement is still demonstrating comparable in vivo exposure. Safety and efficacy data from new trials are not required because the generic is expected to have the same therapeutic effect once bioequivalence is shown. Manufacturing inspections and labeling must meet regulatory expectations, but the central requirement highlighted by this question is proving bioequivalence.