Drugs

Allowable Excess Volume/Content MAPP

The CDER Office of Pharmaceutical Quality (OPQ) has published a Manual of Policies and Procedures (MAPP) describing the policies and procedures for OPQ product quality assessors to ensure consistent assessment of excess volumes in injectable drug products packaged into vials. The MAPP addresses both liquid and solid drug products that require reconstitution/constitution and describes the policies and procedures to be used by OPQ product quality assessors to ensure that the excess liquid or solids filled into vials for injectable drug products is sufficient to allow for withdrawal and administration of the net container content of the drug product.

It also provides procedures for obtaining information in applications in support of excess volumes for single-dose and multiple-dose injectable drug products submitted in NDAs, BLAs, ANDAs, and applicable supplements to the applications. And it includes expectations that should be communicated to NDA, BLA, and ANDA applicants, and IND sponsors as early as possible.

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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