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 To strengthen this commitment, the U.S. Food and Drug Administration (FDA) has released a new draft guidance on postmarket safety labeling changes (SLCs).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 This final document replaces an earlier 2015 version and updates the 2019 draft guidance, reflecting how far the science and regulatory framework have advanced in recent years.
In today’s globalized economy, pharmaceutical supply chains face mounting pressures. Natural disasters, geopolitical tensions, and increasingly complex regulatory requirements have exposed vulnerabilities that threaten patient access to essential medicines. For life science organizations, ensuring continuity of supply is no longer just a competitive advantage, it is a responsibility to patients and regulators alike.
Stability testing remains a cornerstone of pharmaceutical development, providing critical data to ensure that drugs are safe, effective, and consistent throughout their shelf life. The International Council for Harmonisation (ICH) recently released its draft Q1 guideline, consolidating multiple stability guidances into a single, comprehensive document. While the industry has welcomed this effort to streamline and modernize regulatory expectations, stakeholders are also raising important questions about the guideline’s scope and how stability studies should be timed.
A major focus this week has been the continuing fallout from the Trump administration’s reduction-in-force (RIF) initiatives at the Department of Health and Human Services (HHS). According to an investigation by ProPublica, more than 20,500 staff members—or roughly 18% of the department’s workforce—have either been laid off or resigned since January. This includes more than 3,000 scientists, over 1,000 regulators, and numerous public health specialists. The scale of the cuts raises concerns about how well federal agencies can continue to oversee safety, compliance, and research across healthcare sectors.
On-body delivery systems (OBDS) are changing the way patients receive medications, offering convenience, improved adherence, and new opportunities for long-term treatment outside of healthcare facilities. These devices attach directly to the patient’s body and deliver medicines over a set period, often through a needle or soft cannula. As technology advances, OBDS are beginning to incorporate connectivity features such as real-time monitoring, cloud integration, and artificial intelligence (AI), creating a new category of “connected OBDS.” While these innovations bring potential benefits, they also raise important regulatory considerations.
Some FDA approvals have sparked debate, drawing attention from the media, lawmakers, patient advocacy groups, and industry. These controversies often stem from questions about the strength of the evidence, the approval pathway used, or the balance between patient access and safety. This article explores a few of the most discussed FDA approvals in history and the lessons they offer for future regulatory decision-making.
The rapid growth of cellular and gene therapy development has brought groundbreaking opportunities to patients, but it has also introduced new challenges for regulators. The US Food and Drug Administration (FDA) has seen a sharp rise in investigational new drug (IND) submissions, many of which are highly complex. To address this workload and reduce delays, the FDA’s Center for Biologics Evaluation and Research (CBER) reorganized in 2023 to form the Office of Therapeutic Products (OTP). One of OTP’s priorities has been to improve efficiency in reviewing INDs for advanced therapies.