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.
The US Food and Drug Administration (FDA) is receiving significant feedback from industry, patient groups, and academic organizations following the release of its updated draft guidance on safety labeling changes (SLCs). Commenters are seeking more clarity on how the agency identifies new safety signals, how labeling decisions are made, and what information FDA will share publicly throughout the process.
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The U.S. Food and Drug Administration (FDA) has appointed Dr. Richard Pazdur as the new Director of the Center for Drug Evaluation and Research (CDER), following the abrupt resignation of former director George Tidmarsh. The transition marks a major leadership shift for the agency’s largest center, which oversees the regulation of prescription drugs, generics, and therapeutic biologics.
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.
