Drugs

FDA Soliciting CNPV Pilot Interest

FDA says up to five drug and biologic developers will be selected in the first year to participate in the Commissioner’s National Priority Voucher pilot program. An agency statement solicits statements of interest in the pilot that will offer these benefits:

faster review times (1-2 months rather than 10-12 months);
enhanced communication throughout the review process;
multidisciplinary team-based evaluation;
potential for accelerated approval if applicable requirements are met; and
maintaining FDA’s rigorous safety and efficacy standards.

The statement gives two examples of health issues in the U.S. leading to the need for the program — some 75% of young Americans could not qualify for military service without a waiver, often due to obesity and other health conditions, and the vast majority of active pharmaceutical ingredients and drug components come from China.

“The Commissioner’s National Priority Voucher pilot program was designed to accelerate the development and review of certain drugs and biological products that are aligned with U.S. national health priorities and to enhance the health interests of Americans,” the statement says. Specific priorities are given as: addressing a U.S. public health crisis, delivering more innovative cures for the American people, addressing a large unmet medical need, onshoring drug development and manufacturing to advance the health interests of Americans and strengthen U.S. supply chain resiliency, and increasing affordability.

FDA says that companies submitting a statement of interest should be prepared to respond promptly to any agency inquiries about their submission. Submissions will be evaluated by a senior, multi-disciplinary review committee led by the agency’s Office of the Chief Medical and Scientific Officer. Participants will be chosen, FDA says, based on the priorities and application readiness.

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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