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
US FDA’s June User Fee Calendar Starts Out Steady, But A Crescendo Of Decisions Will Start Mid-Month
Two gene therapies and two novel inhibitors of JAK kinases are among the upcoming goal dates from the Pink Sheet’s US FDA Performance Tracker.
Supplemental Filings: FDA Expands In-Person Meeting Eligibility Again; Marks Suggests Sponsors Invite Foreign Regulators To FDA Meetings
More formal meetings are available for in-person sessions with the US FDA. Also, CBER Director Peter Marks offers advice for conducting meetings, from how to do hybrid right to how to include patient groups and foreign regulators.