Drugs

FDA, USP, and Industry Convene to Boost Drug Quality

FDA is joining the United States Pharmacopeia (USP) and the Association for Accessible Medicines (AAM) on 12/11 for a public workshop focused on how compendial standards can strengthen drug quality, streamline development, and improve regulatory predictability across the pharmaceutical industry. According to an FDA notice, the workshop aims to “increase stakeholder awareness of, and participation in, the USP standards development process,” emphasizing the importance of public quality standards as tools that guide the design, manufacture, and regulation of medicines.

Speakers from FDA, USP, and AAM will discuss how USP monographs and related compendial standards contribute to consistent quality and compliance for both brand-name and generic drugs. The session will also explore FDA’s role in USP’s standards-setting process and opportunities for manufacturers, regulators, and consultants to engage through public comment or sponsorship of new standards.

Key topics include:

FDA’s participation in USP standards development and revision;
The role and value of USP monographs in regulatory oversight;
How standards compliance factors into FDA review and enforcement activities;
Industry’s contributions to USP standard-setting; and
The process for proposing and revising USP monographs.

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