MAPP Describes the Work of CDER’s Biopharmaceutics Council

Regulatory NewsRegulatory News
| 10 May 2019 | By Zachary Brennan 

The US Food and Drug Administration’s Office of Pharmaceutical Quality has published a new Manual of Policies and Procedures (MAPP) that explains the organization, membership and procedures of the Biopharmaceutics Council in FDA’s Center for Drug Evaluation and Research (CDER).

The 9-page MAPP, which takes effect on 16 May, defines biopharmaceutics as “a broad-based scientific discipline that studies the effect and interplay of the physicochemical properties of a drug, its dosage form, and the intended route of administration on the rate and extent of the drug’s absorption.”

The Council, while ensuring the biopharmaceutics decisions are consistent across CDER, will meet on a regular basis to consider biopharmaceutics-related issues that are “complex or precedent-setting” and require the attention of senior management.

To be considered a biopharmaceutics-related issue, certain stipulations would need to be met, including if the issue is:
  • “A novel design or approach to address a biopharmaceutics issue
  • A precedent-setting biopharmaceutics policy or practice requiring senior management input
  • A biopharmaceutics issue on which CDER appears to have taken inconsistent positions
  • An existing biopharmaceutics policy position or practice that should be reconsidered in light of scientific or regulatory advances
  • A biopharmaceutics issue that may be triggered by a specific product but will be applicable to other products
  • Significant proposed procedure changes that could have an impact on how a biopharmaceutics assessment is performed
  • Strategies for implementation of a new biopharmaceutics policy or practices
  • Strategies for effective communication of a new or existing biopharmaceutics policy or practice.”
The MAPP also discusses the membership of the Council, as well as what subcommittees and working groups will entail.

MAPP for CDER’s Biopharmaceutics Council


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