Drugs

Botanical Drug Review MAPP Out

CDER has issued a Manual of Policies and Procedures (MAPP) describing the review process for INDs and NDAs for botanical drug products and the role of the Center’s Botanical Review Team in the Office of Pharmaceutical Quality’s Immediate Office. The document says the policies and procedures “are intended to ensure quality and consistency in the review of these products.” It does not cover the review of OTC drug monographs and ANDAs for botanicals.

According to the MAPP, botanical drug products often have unique features such as complex mixtures or substantial prior human experience, such as with traditional medical systems and/or lack of a distinct active constituent, that require special consideration during the review process.

The review team was established to help manage the unique features and review issues associated with botanical drug products, CDER says. The team ensures quality and consistency in the review by acting as an advisory resource to all review divisions and offices in the Office of New Drugs and other CDER review disciplines.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome