Innovation thrives at the intersection of regulatory flexibility and robust oversight, especially within the dynamic field of first-in-class drugs. Today, we delve into this critical topic with Ivan Kairatov, a seasoned biopharma expert with extensive experience in research and development. With a
The Healthcare Regulatory Check-Up Newsletter for February 2025 provides an in-depth overview of significant developments and updates in healthcare regulation, litigation, and policy changes in the United States. This article summarizes key settlements, legal actions, legislative proposals,
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
