ICH Guidelines
ICH Guidelines
ICH Guidelines harmonize technical and regulatory requirements for drug development across the US, EU, and Japan. This collection brings together ICH quality, safety, efficacy, and multidisciplinary guidance documents in one place, a reference for teams navigating global development and registration standards.
The Food and Drug Administration is announcing the availability of a final guidance for industry entitled “E6(R3) Good Clinical Practice.” This revision incorporates flexible, risk-based approaches and embraces innovations in trial design, conduct, and technology.This important milestone marks a significant evolution in the global clinical trial landscape, aiming to modernize...
Office of the Commissioner, Office of Women's Health The objective of this guideline is to provide recommendations for the appropriate inclusion and/or retention of pregnant and/or breastfeeding women in clinical trials and facilitate the generation of robust clinical data that allow for evidence-based decision making on the safe and effective...
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Q1 Stability Testing of Drug Substances and Drug Products.” The draft guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use...
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “M13B Bioequivalence for Immediate-Release Solid Oral Dosage Forms: Additional Strengths Biowaiver.” The draft guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for...
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “E6(R3) Good Clinical Practice: Annex 2.” The draft guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The draft...
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “E11A Pediatric Extrapolation.” The guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The guidance provides a comprehensive and...
This guideline is intended to provide recommendations on conducting bioequivalence (BE) studies during both development and post approval phases for orally administered immediate-release (IR) solid oral dosage forms designed to deliver drugs to the systemic circulation, such as tablets, capsules, and granules/powders for oral suspension. Questions and Answers M13A Bioequivalence...
The Food and Drug Administration (FDA or Agency) is announcing the availability of the final guidance for industry entitled “M12 Drug Interaction Studies” and the supplemental document entitled “M12 Drug Interaction Studies: Questions and Answers.” The guidance and supplemental questions and answers document were prepared under the auspices of the...
The Food and Drug Administration (FDA or Agency) is announcing the availability of the final guidance for industry entitled “M12 Drug Interaction Studies” and the supplemental document entitled “M12 Drug Interaction Studies: Questions and Answers.” The guidance and supplemental questions and answers document were prepared under the auspices of the...
This technical specifications document is to assist interested parties in electronically submitting individual case safety reports (ICSRs) (and ICSR attachments) to the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) in the Food and Drug Administration (FDA or Agency). This document describes...
