Drugs

Drug/Device User Interface MAPP

CDER has published a Manual of Policy and Procedures (MAPP), Assessment of the User Interface of a Drug-Device Combination Product Submitted in a Pre-ANDA Communication or an ANDA, to describe how the Office of Generic Drugs (OGD) and the Office of Surveillance and Epidemiology (OSE) will assess the user interface of a drug/device combination product. The document says the policies and procedures outlined in the MAPP apply to all generic combination products.

The MAPP says OGD and OSE have differing expertise that may inform the review of comparative analysis of generic combination products. It clarifies the roles and responsibilities of each office for the assessment of comparative analyses and comparative use human factors studies, explains when OGD will consult OSE, and outlines OGD’s and OSE’s policy for regularly scheduled meetings between the two groups to support shared learning, awareness, and consistency, where applicable, in the assessment and characterization of user interface differences for combination products submitted under different application pathways.

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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