Drugs

Positron Emission Tomography Meeting Set

The FDA Office of New Drugs will hold an 11/13-11/14 meeting on “Positron Emission Tomography: Product Quality Regulatory Submissions, Facility Inspections, and Benefit-Risk Considerations.” An online notice says the purpose of the session is to provide a forum for the exchange of information and perspectives on the regulatory and compliance framework for positron emission tomography (PET) drug manufacturing. “Bringing all stakeholders together will improve the global understanding of regulatory and compliance topics associated with PET drug manufacturing,” the notice says.

The meeting’s goals and objectives are to:

discuss regulatory compliance for the development and manufacturing of PET drugs and pathways for regulatory application;
share perspectives from industry, academia, investigators, and regulators on inspection findings and trends; and
provide information on the management of Part 212 inspections and maintenance of PET NDAs and ANDAs.

Topics for discussion are listed as:

trends on inspections and compliance;
lifecycle management of PET drug applications;
product quality assurance; and
changing landscape of PET drugs: Labeling, Electronic Submissions.

Session co-hosts are the FDA Office of Regulatory Operations and the Division of Regulatory Operations for Specialty Medicine. Co-sponsors are the Society of Nuclear Medicine and Molecular Imaging, Coalition of PET Drug Manufacturers, and Medical Imaging & Technology Alliance.

Registration information is in the notice.

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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