The article delves into the intriguing potential of real-world evidence (RWE) to revolutionize the U.S. Food and Drug Administration’s (FDA) approval process for new drugs. By relying more on real-world data (RWD), regulatory decisions could become quicker, more economical, and maintain the current
In a groundbreaking initiative aimed at transforming the health regulatory landscape across the African continent, the first African Regulators Leadership Program (ARLP) was convened at the Wits Business School in Johannesburg. This program is designed to elevate the leadership skills and
The hospice industry faces significant regulatory challenges that have become more pronounced in recent years, with key concerns including evolving telehealth policies and program integrity issues. These challenges were highlighted by hospice professionals in the 2025 Outlook Survey conducted by
Clinical trials have long been criticized for their lack of diversity, particularly in the participation of women. Historically, such exclusions have led to significant gaps in medical knowledge and treatment efficacy across genders, resulting in potentially biased outcomes for a substantial
As the Biden administration prepared to leave office, it enacted a significant order titled "HIPAA Security Rule to Strengthen the Cybersecurity of Electronic Protected Health Information." This order could potentially destabilize the healthcare sector's financial and operational stability.
In 2025, Federally Qualified Health Centers (FQHCs) and Community Health Centers (CHCs) across the United States will undergo transformative regulatory changes. These changes will impact data reporting, preventive services billing, and care management billing, necessitating comprehensive
