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# Drug Safety Oversight Board MAPP
- URL: https://www.fdaweb.com/drug-safety-oversight-board-mapp/
- Published: 2016-09-14T12:00:00.000Z
- Updated: 2026-09-14T21:31:49.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5136797

A new Manual of Policies and Procedures (MAPP) describes the organizational structure, roles, and responsibilities of the Drug Safety Oversight Board (DSOB) and its staff within CDER. The [document](http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ManualofPoliciesProcedures/UCM073564.pdf?ref=fdaweb.com) says the DSOB was created in 2005 to provide oversight for the management of drug safety issues in FDA and to provide a forum for internal deliberations on complex safety issues.

The MAPP defines the DSOB as a “multidisciplinary, cross-organizational group of government experts established to provide broad scientific and regulatory recommendations on drug safety and communication issues and policies to the Center director.”

Potentially significant drug risk and safety issues that have broad policy implications or that would benefit from wider input than can be provided by internal discussions within CDER that can go to the DSOB include: 

- selected emerging or ongoing drug-specific safety and risk management issues;
- effective communication of drug safety information to healthcare professionals, patients, and the general public when consultation and feedback is requested by the Center director or the director of the CDER Office of Communications;
- establishment of general policies regarding drug safety issues and approaches to resolving internal policy differences;
- drug safety issues on which there is substantial internal disagreement;
- disputes between a sponsor and CDER about a REMS (risk evaluation and mitigation strategy) that occurs after approval of a prescription product if the sponsor requests DSOB review; and
- other issues as deemed appropriate by the Center director.

Involvement in reviewing REMS disputes was added to DSOB responsibilities by the 2007 FDA Amendments Act. The MAPP notes that referral of a REMS dispute to the DSOB does not preclude use of other venues for discussing and resolving the disputes, and additional efforts to resolve the dispute may be pursued.