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Pharmaceuticals / Regulatory Affairs

FDA Takes Industry Comments on Ad Regulations, User Fee Waivers and ICH Safety Reports

May 25, 2017

The FDA is requesting industry comments on two separate guidances and the agency’s regulations for prescription drug advertisements. The guidances cover applications for user fee waivers, reductions and refunds, as well as submitting post-market periodic safety reports in the ICH format.

The agency is aiming to minimize regulatory burdens on companies related to disclosure requirements for print and broadcast advertisements. The FDA estimated that it receives more than 570 voluntarily submitted advertisements for agency comment prior to publication each year, and that companies spend nearly over 18.1 million hours annually complying with advertising regulations, including summaries of product risks and benefits.

For user fee waivers, the FDA published a 2015 guidance describing the information necessary for a request, and is inviting industry to comment on the process. Companies must seek a waiver to submit safety reports in the ICH Periodic Benefit-Risk Evaluation Report format instead of the FDA’s format. The agency recommends this process if companies must submit safety reports to multiple international authorities, including the European Union and Japan. Details can be found in the FDA’s guidances on ICH E2C(R2), published in July and November 2016.

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