Generic drugs don’t need lengthy clinical trials to support a submission seeking FDA approval. The regulator now proposes ending this testing requirement for biosimilars, products that reference complex biologic medicines.
Drugs selected for the FDA’s new Commissioner’s National Priority Review Voucher pilot program could receive a regulatory decision in two months or less. Qualifying product candidates must address a national priority, such as filling an unmet medical need or boosting domestic drug manufacturing.
Richard Fu details the company's approach to nutrition therapy and strategy for patients using GLP-1s.
Value-based care promises to right the wrongs of fee-based healthcare. But today, we’re a long way from a value-based system. One way to get there faster? Prioritize access to data.
Despite all the noise around the updates, there’s one area that’s been conspicuously absent this year: enforcement of patient estimate requirements.
The proliferation and rapid adoption of AVT in clinical settings has not gone unnoticed, and NHS England has made it clear that the use of these tools must now meet stringent compliance standards.
The longer we delay, the further we shift costs from polluters to patients — and to every taxpayer who funds Medicare, Medicaid and community hospitals. Environmental stewardship and human health are inseparable; regulating microplastics is preventive medicine on a national scale.
Across the nation, state-based health insurance exchanges are searching for ways to better serve their communities while making enrollment easier, more personal, and more accessible for everyone.
The cell and gene therapy sector has hit incredible milestones in recent years. As the sector continues to evolve and the climate becomes increasingly crowded and volatile, leaders must remain flexible in constantly refining the pipeline.
Without systemic redesign, these efforts risk reinforcing the same pain points that made prior authorization a flashpoint for payers and providers.
Inaccuracies don’t just erode trust — they lead directly to surprise billing events, missed appointments, care delays, and in some cases, enforcement action.
Although the healthcare industry has a long way to go before PGx testing for DPYD and other genes becomes widespread, it's encouraging that regulatory bodies and professional organizations are making recommendations and raising awareness among healthcare providers.
How Apella leverages technology to increase OR efficiency.
From the operating room to the front desk, robotics are now being integrated into a variety of applications with the purpose of freeing up time and services for healthcare workers to do what they do best, patient care.
The conversations in Nashville reinforced the idea that while innovation remains essential, vendors must navigate the fine balance between bold ideas and real-world implementation, demonstrating not just promise but tangible outcomes.
While new technologies may demonstrate clinical benefits in controlled settings, their true value is determined by how well they fit into existing healthcare workflows.
The transition to hybrid measures in 2024 has been more than just a regulatory requirement — it's been a catalyst for meaningful change in how we approach quality reporting. Here are five critical insights that can help healthcare organizations comply with requirements and excel in their quality reporting journey.
AI/big data haven't solved healthcare's challenges. Despite advancements, systemic barriers persist, but AI offers potential to improve outcomes and efficiency.