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FDA pushes "consumer-friendly" presentation of quantitative data in DTC promotions

USA - October 17 2018 On Tuesday, the Food and Drug Administration (FDA or the agency) published a draft guidance document, "Presenting Quantitative Efficacy and Risk...

Cailin Lechner, Jane Kalinina, Meredith Manning, Susan S. Lee.

FDA Issues Draft Guidance on Requirements for Public Warnings for Recalled Products

USA - January 26 2018 FDA recently released a draft guidance clarifying the regulatory requirements for public warnings in the event of a recall under the agency’s recall...

Robert Church, Meredith Manning.

New Rule Amends FDA’s Citizen Petition Regulations to Implement Section 505(q) of the Food, Drug, and Cosmetic Act

USA - December 4 2016 The U.S. Food and Drug Administration (FDA) has issued a final rule implementing section 505(q) of the Federal Food, Drug, and Cosmetic Act (FDCA)...

David M. Fox, Jason F. Conaty.

Let’s Get Real: Meredith Manning Urges FDA to Allow Greater Communication of Real World Data Within Its Current Regulatory Framework

USA - November 7 2016 On October 26, 2016, Hogan Lovells partner Meredith Manning submitted a comment to the U.S. Food and Drug Administration (FDA) urging the agency to...

Meredith Manning.