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In Brief: Advertising Regulation, Vansen Consumer, Star Scientific

This article was originally published in The Tan Sheet

Executive Summary

Supplement firms’ claims referred to FDA, FTC; review prompts new script for Zvelt ads; Vansen starts consumer portfolio with Canadian deal; Star Scientific pivots to drug development; and more In Brief.

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AER Electronic Filing Rule Sets Exemption Bar At Disaster Level

FDA requires firms to submit post-market safety reports for drugs and biologics electronically beginning in June 2015. The agency says waivers will be allowed, but only will be temporary and rare, such as when disasters cut off electric power and Internet access.

AER Electronic Filing Rule Sets Exemption Bar At Disaster Level

FDA requires firms to submit post-market safety reports for drugs and biologics electronically beginning in June 2015. The agency says waivers will be allowed, but only will be temporary and rare, such as when disasters cut off electric power and Internet access.

Star Scientific IND Blocks Supplement Marketing Options – FDA

An FDA warning letter deems Star Scientific’s CigRx and Anatabloc supplements unapproved drugs due to multiple issues, including claims. The firm’s approved IND study for the ingredient also prevents its use in supplements, the agency says.

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