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FDAnews Drug Daily Bulletin

CDER Publishes MaPP on Managing Financial Disclosures in NDAs, BLAs

June 27, 2017

CDER’s Office of New Drugs established policies and procedures for review staff for the management of financial disclosure information submitted in NDAs, BLAs and supplemental applications.

The addition to CDER’s Manual of Policies and Procedures, effective June 21, encourages review teams to work with sponsors and clinical investigators to ensure studies are designed to minimize potential bias and financial conflicts of interest. This would include equity interests in the study sponsor, or proprietary interests in the investigational product.

Identified interests or arrangements will be discussed at end-of-Phase II meetings, as well as pre-IND and pre-NDA meetings if necessary, the MaPP said. If required disclosure information is not submitted before the application filing date, sponsors will receive a notice from the OND regulatory project manager.

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