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a major step toward streamlining biosimilar development, the U.S. Food and Drug Administration (FDA) has proposed new draft guidance that could remove the need for comparative efficacy studies (CES) in most biosimilar applications.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.
The liver is one of the body’s most resilient organs. Every day, it works overtime to process alcohol, medications, and even the occasional junk food—quietly repairing itself in the background. But new research suggests that when the damage becomes chronic, the liver can reach a point of no return, losing its extraordinary ability to heal.
The U.S. Food and Drug Administration (FDA) announced it will not accept regulatory submissions that require user fees during the ongoing government shutdown, which began October 1 after Congress failed to reach a funding agreement. While the agency will continue to conduct mission-critical activities, the pause underscores the vulnerability of regulatory operations during federal funding lapses.
For decades, ready-to-eat cereals have been marketed as the cornerstone of a “healthy breakfast.” Bright packaging, celebrity endorsements, and claims like “heart healthy” or “part of a balanced diet” line grocery store shelves. But recent studies suggest that many of these cereals may not live up to their healthy image—and for consumers, this raises important questions about transparency in nutrition labeling and food marketing.
Generic drugs remain essential for healthcare systems worldwide, but evolving formulations, delivery systems, and safety concerns require increasingly sophisticated approaches to regulation. FDA’s updated priorities aim to strengthen scientific understanding, modernize review processes, and make the development of generics more efficient.
In the high-stakes world of pharmaceuticals and life sciences, regulatory submissions are the final gateway between development and patient access. Yet, this critical step is often bogged down by complexity—mountains of documents, global variations in requirements, manual formatting errors, and the looming risk of costly delays.
Ensuring patients have access to the most accurate and up-to-date safety information is one of the FDA’s highest priorities. To strengthen this commitment, the U.S. Food and Drug Administration (FDA) has released a new draft guidance on postmarket safety labeling changes (SLCs). The proposal updates the agency’s 2013 guidance and incorporates new authorities granted under the 2018 SUPPORT Act, which expanded FDA’s ability to require manufacturers to communicate emerging safety concerns.
The U.S. Food and Drug Administration (FDA) has finalized its long-awaited guidance on comparative analytical studies for therapeutic protein biosimilars, providing much-needed clarity for developers navigating the complex biosimilar approval process. This final document replaces an earlier 2015 version and updates the 2019 draft guidance, reflecting how far the science and regulatory framework have advanced in recent years.
