Drugs

9 Applicants Chosen for Drug Quality Evaluation

CDER Office of Pharmaceutical Quality acting deputy director of science Susan Rosencrance says the agency has chosen nine applicants for a new Quality Management Maturity (QMM) evaluation program. Speaking at the agency’s Generic Drugs Forum, Rosencrance said the QMM program encourages manufacturers to implement quality management practices that go beyond current good manufacturing practices. She described how QMM benefits patients/consumers, industry, and FDA.

Rosencrance used much of her presentation to review the work being done by OPQ as shown in its State of Pharmaceutical Quality report and 2023 Annual Report.

She highlighted the annual report metrics showing that OPA performed quality assessments on over 1,100 product applications, including 118 new drug applications, 956 generic drug applications, and 29 biologic license applications. It also supported 55 novel drug approvals and conducted 359 expedited assessments to address drug shortages and 28 primary assessments for orphan diseases.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

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