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July 21, 2022
Draft Guidance July 2022 This guidance is intended to assist applicants in incorporating dose banding information into the drug labeling provided in a new drug application (NDA) submitted under the...
July 20, 2022
FDA Draft Guidance July, 2022 As part of the FDA’s continued efforts to provide helpful information to regulated industry and the public, the agency has published a draft guidance for industry,...
July 19, 2022
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...
July 14, 2022
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...
July 13, 2022
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...
July 8, 2022
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....
July 7, 2022
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...
July 5, 2022
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...
July 5, 2022
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...