Drafting Perfect 483 Responses: The New FDA Guidelines Explained. FDA Form 483 observations are issued when investigators identify conditions that may violate cGMP requirements.
Embrace eBMR : 3 Key elements to Meeting Global Pharma Regulations – EU Annex 11; 21 CFR 11; Data Integrity – The core purpose of The Digital Imperative relating to eBMR application is to document every step of the manufacturing process
Pharmacovigilance, the science, and activities related to detecting, assessing, understanding, and preventing adverse effects or other drug-related problems, is critical in patient safety.
The U.S. Food and Drug Administration (FDA) has recently updated the required warning information in the labeling for mRNA COVID-19 vaccines manufactured by Moderna and Pfizer-BioNTech.
Health Canada has released a new Draft Good Manufacturing Practices (GMP) Guide for Natural Health Products (NHPs), marking a significant update in the regulation of supplements, herbal remedies, vitamins, and other natural health products in Canada. If you’re a manufacturer, distributor, or consumer of NHPs, this draft guide is worth paying attention to—it could shape