Introduction Over-the-counter medicine is also known as OTC or nonprescription medicine. All these terms refer to medicine that you can buy without a prescription. The questions below are designed to help understand what OTC medications are, their uses, and important considerations when using them. What are Over-the-Counter (OTC) Drugs? Over-the-Counter

Introduction The new regulations established by the FDA for nonprescription drug products that include an additional condition for nonprescription use (ACNU) are designed to enhance consumer access to safe and effective medications while ensuring proper self-selection and usage without the need for a prescription. What is a nonprescription drug product

Introduction The ICH Q14 Guideline is an international guideline that outlines science and risk-based approaches for developing and maintaining analytical procedures used to evaluate the quality of drug substances and products. It ensures that analytical methods are fit for their intended purpose and focuses on both traditional and enhanced development

Introduction Navigating the complexities of GxP regulations can be challenging. This FAQ section provides valuable insights into common questions related to GxP compliance, including the consequences of non-compliance, the importance of a robust Quality Management System (QMS), and a deeper dive into Good Clinical Practice (GCP) and Good Manufacturing Practice