Regulatory Blog

Therapeutic equivalence is an important consideration when evaluating multisource prescription drug products and their potential substitution. The U.S. Food and Drug Administration (FDA) uses therapeutic equivalence evaluations to determine whether certain approved drug products can be expected to have the same clinical effect and safety profile when used under the conditions specified in their labeling. The FDA has issued the Guidance for Industry: Evaluation of Therapeutic

Active immunotherapy products (ACTIMPs) are designed to treat existing diseases or conditions by inducing, stimulating, or modulating immune responses. Because their therapeutic effect depends on the interaction between the product and the immune system, demonstrating and maintaining product potency is an important part of development. The FDA has issued draft guidance on Potency Assessment of Active Immunotherapy Products, providing recommendations for developing and evaluat

Choosing the appropriate abbreviated approval pathway is an important consideration when developing a drug product for submission to the U.S. Food and Drug Administration (FDA). The pathway selected determines the type of information and data that can be used to support the application. The FDA has published the Guidance for Industry: Determining Whether to Submit an ANDA or a 505(b)(2) Application, which provides recommendations to help applicants determine whether a propose