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  1. Economic Impact Analyses of FDA Regulations

Biologics License Applications and Master Files (Proposed Rule) Preliminary Regulatory Impact Analysis

The Food and Drug Administration (FDA) proposes to amend its regulations concerning the use of master files for biological products. The proposed rule, if finalized, would clarify that deemed BLAs that originally referenced drug master files (DMFs) for drug substance, drug substance intermediate, or drug product (DS/DSI/DP) information in an approved NDA can continue to do so after March 23, 2020. The proposed rule would also codify the requirements for the use of master files by current and future BLA holders and sponsors of INDs for biological products.

This Preliminary Regulatory Impact Analysis discusses the economic impacts of the proposed rule, including potential costs, cost savings, and benefits. The proposed rule, if finalized, would generate net cost-saving benefits for the private and government sectors. Furthermore, the proposed rule would promote continuity and avoid potential disruptions in the supply of biological products deemed BLAs on March 23, 2020.

Regulatory Impact Analysis

Biologics License Applications and Master Files (Proposed Rule) Preliminary Regulatory Impact Analysis (PDF - 141KB)

Federal Register: 84 FR 30968. June 28, 2019

Docket: FDA-2019-N-1363