Drugs

China Speeding Drug Approvals: CIRS Briefing

A Center for Innovation in Regulatory Science (CIRS) briefing paper says that in recent years, there has been significant progress in reducing delays in new drug approvals in China. The latest CIRS briefing looks at new active substance (NAS) approvals in Australia, Canada, China, Europe, Japan, Switzerland, and the U.S. It finds that as of 1/2025, there were 27 NASs that were approved by all seven regulators and thus were considered to be internationalized medicines.

The report says approval timelines for China’s National Medical Products Administration were comparable to those of the other agencies, with a median of 390 days. Submission strategies vary, it says, with FDA typically being first and China often being last, although it finds that some companies are now prioritizing earlier China submissions.

Some 11 of the 25 internationalized NASs were submitted to all seven regulatory agencies within two to three years, while six NASs achieved full global submission within one year.

“This briefing highlights the evolving role of China in global regulatory strategies and the importance of coordinated submissions to accelerate patient access,” the document concludes.

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