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FDA Officials Offer Pointers For Navigating Social Media Pitfalls

This article was originally published in The Tan Sheet

Executive Summary

FDA officials acknowledge ensuring the accuracy of all claims consumers make online about products is impossible, but the agency will hold firms accountable for information on or linked to their Web sites

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GMP Inspectors Will Scrutinize Adverse Event Reporting Compliance

Regular under-reporting of serious adverse event reports has spurred FDA to have its good manufacturing practice inspectors review dietary supplement firms’ AERs and reporting practices, FDA’s Fabricant says. Key compliance issues can tip off the agency that a company may be falling short on reporting.

GMP Inspectors Will Scrutinize Adverse Event Reporting Compliance

Regular under-reporting of serious adverse event reports has spurred FDA to have its good manufacturing practice inspectors review dietary supplement firms’ AERs and reporting practices, FDA’s Fabricant says. Key compliance issues can tip off the agency that a company may be falling short on reporting.

GMP Inspectors Will Scrutinize Adverse Event Reporting Compliance

Regular under-reporting of serious adverse event reports has spurred FDA to have its good manufacturing practice inspectors review dietary supplement firms’ AERs and reporting practices, FDA’s Fabricant says. Key compliance issues can tip off the agency that a company may be falling short on reporting.

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