The FDA’s Generic Drug User Fee Amendments (GDUFA III) are designed to enhance the review process for ANDAs (Abbreviated New Drug Applications), ensuring faster, more efficient access to affordable medications. Here’s what you need to know: Purpose: Provides guidance on how amendments to ANDAs (Abbreviated New Drug Applications) or PASs

Introduction: PSG meetings are crucial touchpoints between the FDA and ANDA applicants, designed to ensure your bioequivalence (BE) studies align with the latest regulatory requirements. These meetings help streamline the approval process by providing clear guidance on BE study designs, enabling compliance with FDA standards, and reducing potential roadblocks in

Introduction: The ICH Q14 Draft Guideline on Analytical Procedure Development, endorsed on March 24, 2022, outlines a science and risk-based framework for developing and maintaining analytical procedures essential for evaluating the quality of drug substances and products. This document is currently under public consultation as part of the ICH process.

The FDA has finalized a significant rule aimed at establishing requirements for nonprescription drug products that include an Additional Condition for Nonprescription Use (ACNU). This initiative is designed to enhance consumer access to safe and effective medications while ensuring that individuals can self-select and use these products without the need

The M13A Bioequivalence Guidance for Immediate-Release Solid Oral Dosage Forms, issued by the FDA, provides comprehensive recommendations for conducting bioequivalence (BE) studies. Here’s a summary of the key points from the guideline: Introduction: Objective: The guideline aims to offer recommendations for BE studies during both development and post-approval phases for