USA – MAPP Describes the Work of CDER’s Biopharmaceutics Council

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…