CRN priorities for CFSAN
This article was originally published in The Tan Sheet
Executive Summary
The Council for Responsible Nutrition asks FDA to prioritize providing guidance and conducting stakeholder meetings with industry on implementing the dietary supplement good manufacturing practices final rule, CRN says in comments submitted Aug. 29. Other CRN recommendations include FDA adding reviewers to expedite the Center for Food Safety and Applied Nutrition's evaluation of adverse event reports, which supplement and OTC firms will be required to submit beginning in December under the AER law Congress enacted in 2006, and to amend the MedWatch form to include space to indicate whether consumers say they will allow their physicians to speak with firms' medical representatives (1"The Tan Sheet" Aug. 20, 2007, p. 13)...
You may also be interested in...
AHPA Asks FDA To Allow Firms To Route AER Contact To Offices Outside U.S.
FDA's guidance on adverse event reporting for OTC drugs and dietary supplements should assure that firms operating outside the country can use U.S. addresses on their product labels but receive AER-related communication in their home countries, the American Herbal Products Association recommends
Sanofi Prepares Pulmonologists As Dupixent Nears COPD Finishing Line
The French drugmaker has identified education as a key challenge ahead of its June action date for the huge-selling IL4/IL-13 inhibitor in the lung condition. An approval would make it the first biologic for the disease.
Global Pharma Guidance Tracker – March 2024
Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.