Drugs

2 New MAPPs Out

FDA has released two new CDER Manuals of Policies and Procedures (MAPPs). The first, Scientific Interest Groups: Criteria and Policies, outlines the process and requirements for creating a scientific interest group (SIG) in the CDER Office of Clinical Pharmacology (OCP). The MAPP says a SIG is a group of volunteer members with a common interest in a particular scientific topic. Examples of SIG activities, which differentiate it from a working group, are journal clubs, hands-on training experiences, cross-specialty training, lectures and seminars, and development and discussion of better science and tools used by OCP.

OCP says it encourages the formation of SIGs as a means to support professional development based on personal scientific interests, develop increased scientific expertise within OCP, and provide opportunities for mentorship within OCP.

The second MAPP, CDER Data Standards Program, establishes the operating model to support the development and implementation of data standards in CDER. It also defines decision-making authorities, roles, and responsibilities, and assigns accountability for the ongoing governance, daily operations, and project processes of CDER’s data standards.

CDER says the current lack of standardized data creates challenges to conducting thorough and well-organized reviews of the vast and growing amount of data the agency receives in a variety of regulatory submissions from a multitude of sources and in a variety of formats.

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FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

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FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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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