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FDA to Hold Two-Day Conference on Off-Label Product Use

September 8, 2016

Nearly two years after the agency said that it would review its regulatory framework on off-label use, the FDA announced that it would hold a meeting Nov. 9 and 10 to involve stakeholders in the framing of guidance and regulations on unapproved uses.

The agency is engaging stakeholders to ensure that its regulations and guidance documents serve to ensure drugmakers provide sound information to health care professionals.

The industry groups PhRMA and BIO have been pressing the FDA to revisit its off-label standards.

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