Dr. Vinay Prasad has stepped down from his role as Director of the FDA’s Center for Biologics Evaluation and Research (CBER), less than three months after taking the post. His sudden resignation marks a significant leadership shift for the agency’s oversight of vaccines, cell therapies, and gene therapy products.
As the demand for cost-effective biologic therapies continues to grow, biosimilars have emerged as a critical solution for improving patient access to life-saving treatments. These FDA-approved biologic alternatives closely resemble existing reference products and offer a more affordable option without compromising safety or efficacy.
A Pre-Biologics License Application (Pre-BLA) meeting is a critical milestone in the regulatory pathway for biologic products. This meeting is held between a biologic product sponsor and the FDA before the submission of a Biologics License Application (BLA). The primary goal is to discuss the forthcoming BLA submission, ensuring that it meets all regulatory requirements and addresses any potential issues that could delay the approval process.
In this blog, we delve into the BLA process to shed light on its intricacies and provide insights for biopharmaceutical innovators.
In this blog, we will delve into the intricacies of the BLA process, exploring its significance, key components, and the steps involved in bringing a biologic product to market.
In this blog post, we will delve into the essential aspects of the BLA process, shedding light on the steps involved and the significance of each stage.
Pharmaceutical manufacturers and industry organizations are urging the U.S. Food and Drug Administration (FDA) to broaden the scope of its PreCheck program, an initiative designed to encourage domestic pharmaceutical manufacturing. Stakeholders argue that extending eligibility to include existing facilities—not just new ones—would accelerate the program’s impact and strengthen U.S. supply chain resilience.
In a major step toward streamlining biosimilar development, the U.S. Food and Drug Administration (FDA) has proposed new draft guidance that could remove the need for comparative efficacy studies (CES) in most biosimilar applications. The move signals a shift toward science-based, analytical methods that rely on advanced testing—reducing the time, cost, and complexity of bringing biosimilars to market.
The checklist provides sponsors with detailed criteria for submission completeness—criteria that FDA reviewers already use internally to determine whether an application is ready for formal review or subject to a Refuse-to-File (RTF) decision. By making these internal tools public, FDA aims to help sponsors better prepare their applications before submission, saving time and resources for both applicants and reviewers.
As the government shutdown stretches into its second week, the U.S. Food and Drug Administration (FDA) continues to operate under constrained conditions—managing leadership changes, new product approvals, and emerging regulatory updates. Here’s a look at the most significant developments shaping this week across the FDA and the broader life sciences landscape.
