What is typically NOT required for an ANDA submission?

For an Abbreviated New Drug Application (ANDA) submission, safety studies are not typically required because the ANDA process is designed for generic drugs that are intended to be therapeutically equivalent to an already approved brand-name drug. The safety profile of the active ingredient has already been established and documented in the original New Drug Application (NDA).

In contrast, the other components listed are crucial for ANDA submissions. Bioequivalency studies are necessary to demonstrate that the generic product behaves in the same way as the brand-name drug, ensuring that it delivers the same therapeutic effect. Manufacturing process approvals are essential to confirm that the facilities and processes used to produce the generic drug meet regulatory standards for quality. Lastly, labeling requirements must comply with regulations to ensure that the information provided to healthcare providers and patients accurately reflects the drug's uses, risks, and benefits.

Thus, the focus of an ANDA is to streamline the approval process for generics while relying on existing safety data from the innovator product, making safety studies not applicable for this type of submission.