Regulatory Blog

Introduction This guidance, "Physicochemical and Structural (Q3) Characterization of Topical Drug Products Submitted in ANDAs ", published in March 2026 , provides detailed recommendations for applicants submitting Abbreviated New Drug Applications (ANDAs)  for topical drug products. It focuses on physicochemical and structural (Q3) characterization, which plays a critical role in demonstrating product performance and bioequivalence (BE). Topical products, especially semisoli

This guidance, " Submitting an application for review by the ACBS, "  explains how to submit an application to the Advisory Committee on Borderline Substances (ACBS) . The ACBS evaluates products that may be considered borderline between foods and medicines, particularly for use within the NHS. The guidance provides a structured approach to ensure that applications are complete, accurate, and suitable for review. Purpose of the Application Process The purpose of this  guidanc

This guidance, " Archiving and retention of clinical trial records, "  explains the requirements for archiving and retaining clinical trial records. Proper archiving is essential to ensure that trial data remains accessible, accurate, and verifiable  over time. It supports regulatory compliance and ensures that clinical trials can be reviewed, inspected, or audited when required. Purpose of Archiving and Retention The purpose of this guidance  is to ensure that essential cli