Drugs

OPQ Supported 55 Novel Drug Approvals in 2023

The CDER Office of Pharmaceutical Quality (OPQ) annual report for 2023 says it supported 55 novel drug approvals, including 17 biotechnology products. The report also credits OPQ with 359 expedited quality assessments to address drug shortages, 28 priority assessments to address orphan diseases, and 65 pre-license inspections in 10 states and 18 countries. Those accomplishments were listed under the OPQ Collaboration strategic priority. Other priorities and their accomplishments were:

Communication
- supported the release of 10 guidances;
- published seven Manuals of Policy and Procedures and two compliance programs;
- released the 6/2023 report on the State of Pharmaceutical Quality;
- published more than 90 articles in peer-reviewed literature; and
- participated more than 350 times in public workshops, conferences, and webinars;
Engagement
- developed 12 CDER workshops and events;
- hosted the biennial Pharmaceutical Quality Symposium for nearly 7,000 virtual attendees from 122 countries;
- developed seven international guidelines on quality topics;
- evaluated two submissions alongside other global regulators in international pilot programs;
- participated in 119 U.S. Pharmacopeia expert bodies; and
- published two papers on Quality Management Maturity;
Innovation
- accepted 15 proposals to the Emerging Technology Program;
- hosted a two-day public workshop and published a white paper on artificial intelligence in drug manufacturing;
- published a paper summarizing the stakeholder feedback on the regulatory framework for distributed manufacturing;
- hosted a public workshop supporting the 12/2023 release of a draft guidance on the Advanced Manufacturing Technologies Designation Program; and
- Knowledge-aided Assessment and Structured Application streamlined the assessment of nearly 1,440 applications.

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