AER guide
This article was originally published in The Tan Sheet
Executive Summary
The Institute for Health Research is publishing an Adverse Events Reporting guide for marketers of natural products and dietary supplements who use neutral third-party AE screening companies in order to meet the standards suggested by FDA's draft AER guidance, the institute announces Oct. 13. Available online at AER-Consulting.com, the guide will also be "invaluable in the future to determine drug and non-pharmaceutical interactions," the NGO adds. FDA's Center for Food Safety and Applied Nutrition posted the draft guidance on its Web site Oct. 11; the law goes into effect Dec. 22 (1"The Tan Sheet" Oct. 15, 2007, p. 4)...
You may also be interested in...
Supplement AER Draft Guidance Omits Answers, But Recognizes Complexities
FDA's draft guidance for dietary supplement adverse event reports encourages firms to employ health care professionals to take information from consumers and other sources of adverse event calls
Japan Grants Global-First Approval To Zolbetuximab, 15 Other New Drugs
Astellas's first-in class CLDN18.2-targeting antibody receives its first approval worldwide, while crovalimab and a number of drugs for rare diseases also receive nods from regulators and are now awaiting reimbursement price-listing.
Hanmi-OCI Merger Hits Wall As Brothers Win Shareholder Vote, Board Seats
The planned merger of Korea's Hanmi Pharm Group with OCI Group hits a major speed bump as the two sons of Hanmi's founder and other candidates recommended by them secture board seats. But it remains to be seen how the Lim brothers will fulfil their ambitious promises.