Clinical Research Solutions
FDA Draft Guidance July, 2022 As part of the FDA’s continued efforts to provide helpful information to regulated industry and the public, the agency has published a draft guidance for industry,...
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EMA Pre-authorisation guidance Table of contents 1. Types of applications and applicants 2. Steps prior to submitting the application 3. Preparing the dossier 3.1 Product name, product information...
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The U.S. Food and Drug Administration has issued a final guidance, “Instructions for Use – Patient Labeling for Human Prescription Drug and Biological Products – Content and Format.” The Instructions...
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The Good Clinical Practice (GCP) Inspectors Working Group has developed procedures for the coordination, preparation, conduct and reporting of GCP inspections requested by the European Medicines...
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July 2022 The purpose of this guidance is to help animal food facilities develop a food safety plan that complies with FDA’s Hazard Analysis and Risk-Based Preventive Controls requirements....
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This guidance document aims to provide interested parties with appropriate guidance on procedural aspects to facilitate the consultation procedure to the European Medicines Agency (EMA) by notified...
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FDA Issues Two Draft Guidances Related to the Drug Supply Chain Security Act FDA is announcing the availability of two guidances to help trading partners comply with the Drug Supply Chain Security...
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In 2020, the European Commission (EC) requested EMA and European Food Safety Authority (EFSA) for advice for the development of a harmonised approach on exposure assessment methodologies for residues...
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Today, the U.S. Food and Drug Administration (FDA) issued a draft guidance, “Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments.” This...
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Final Guidance June 2022 This guidance provides recommendations on an alternate electronic format for submissions covered under an exemption from or a waiver of the requirements of section 745A(a) of...