We explore the impact of AI on pharmacovigilance, the benefits it offers, and the regulatory implications that accompany its adoption.
Category: Patrick John Gora
The Role of Companion Diagnostics in Precision Medicine: Regulatory Challenges and Market Trends
CDx development and approval face significant regulatory hurdles, and the market dynamics for these diagnostics continue to evolve.
Essential Components of a Strong Regulatory Dossier for Medical Devices
The dossier reflects the manufacturer’s commitment to quality, safety, and transparency, helping to establish trust with regulators, healthcare providers, and patients alike.
Understanding Combination Products: Regulatory Requirements for Devices with Drug or Biologic Components
A comprehensive overview of combination products, their regulatory requirements, and the pathways to navigate these challenges.