MedWatch training course
This article was originally published in The Tan Sheet
Executive Summary
FDA has launched an online training seminar on MedWatch and patient safety aimed at health care professional students, practitioners and consumers, the agency announces Jan. 30. The course outlines the agency's role in post-marketing safety surveillance for medical products, describes the reporting to MedWatch, discusses how reports are used by FDA and identifies ways MedWatch disseminates safety information about medical products, FDA states. As part of the recently enacted Dietary Supplement and Nonprescription Drug Consumer Protection Act, adverse events for supplements and monographed OTCs must be submitted using the MedWatch form (1"The Tan Sheet," Dec. 18, 2006, p. 4)...
You may also be interested in...
Adverse Event Collection Expected To Be In Force By Christmas 2007
Firms that make, pack or distribute dietary supplements and over-the-counter drugs approved under monographs will likely have to be in compliance with a new adverse event reporting law by late December 2007
EU Regulatory Assessors Get AI Boost In Reaching Scientific Decisions
The European Medicines Agency is training scientific staff working for the European medicines regulatory network in how to use a new AI-powered search engine that allows them to easily retrieve information on regulatory precedents.
EU Parliament Stricter Than Council On Medicines And Medical Devices Packaging
The EU Parliament's Environment, Public Health and Food Safety committee takes a compromise position with regards to the Packaging and Packaging Waste Directive. Medicines and medical devices should be exempt, but only until 2035, at which point the European Commission should check whether the development of materials and the recycling process have progressed, and may adjust this exemption accordingly.