Regulatory

Navigating Medtech Challenges: Regulatory, Reshoring, and Tech Gaps
Management & Regulatory Navigating Medtech Challenges: Regulatory, Reshoring, and Tech Gaps

The medical and life sciences manufacturing sector is experiencing rapid transformations, bringing forth a plethora of challenges and opportunities for industry professionals. Ascential's "2025 State of Medical & Life Sciences Manufacturing" report delves into key areas such as

Will Mehmet Oz Revolutionize Telehealth with New CMS Policies?
Management & Regulatory Will Mehmet Oz Revolutionize Telehealth with New CMS Policies?

The rapid advancements in telehealth have been met with a mixture of enthusiasm and concern, especially as regulatory frameworks struggle to keep pace with technological innovations. At the center of this challenge is Mehmet Oz, the newly appointed Administrator of the Centers for Medicare

Novartis' Vanrafia Approved by FDA for Rare Kidney Disease Treatment
Management & Regulatory Novartis' Vanrafia Approved by FDA for Rare Kidney Disease Treatment

Ivan Kairatov is a recognized authority in the biopharma sector, with an extensive background in technological advancements and R&D. In this interview, Ivan shares his insights on the new FDA-approved treatment for IgA nephropathy (IgAN), shedding light on its significance in treating this rare

HHS Layoffs and Reorganization Spark Opposition and Legal Action
Management & Regulatory HHS Layoffs and Reorganization Spark Opposition and Legal Action

The U.S. Department of Health and Human Services (HHS) is experiencing a turbulent phase marked by extensive layoffs and a major reorganization under Secretary Robert F. Kennedy Jr. These moves have ignited substantial controversy and legal battles, drawing sharp reactions from various stakeholders

FDA vs. EMA: Which Agency Balances Innovation and Safety Better?
Management & Regulatory FDA vs. EMA: Which Agency Balances Innovation and Safety Better?

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

February 2025 Healthcare Regulatory Updates and Major Legal Actions
Management & Regulatory February 2025 Healthcare Regulatory Updates and Major Legal Actions

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,

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