Drugs

BsUFA 3 Public Meeting Looking at New Proposals

An 11/19 Biosimilar User Fee Act (BsUFA) reauthorization public meeting is likely to hear proposals for potential enhancements or efficiencies for the biosimilar product development and review process. That’s an expectation voiced by CDER Office of Therapeutic Biologics and Biosimilars director Sarah Yim in a CDER Conversation.

She says she also expects to hear proposals toward maximizing scientific and regulatory clarity and other enhancements, such as a possible regulatory science program to provide additional information that could enable more efficiency in safety or efficacy assessment, such as data from real-world experience, pharmacodynamic biomarkers, and immunogenicity response.

Yim says the purpose of the virtual public meeting is to provide interested stakeholders an opportunity to offer their views on the program’s reauthorization as the agency considers which, if any, features to propose, update, or discontinue in BsUFA 3.

The post includes a basic overview of the BsUFA as a lead-in to the reauthorization meeting. Yim notes that the BsUFA 2 reauthorization focused on areas including (1) continued improvements to review processes and procedures, meeting management goals, and processes for reviewing biosimilar products; (2) implementing an application review model for original 351(k) BLAs to promote the efficiency and effectiveness of the first cycle review process and minimize the number of review cycles needed for approval; and (3) offering drug sponsors clearer pathways for biosimilar development, improved predictability, and consistency across drug review processes.

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