We use cookies to customise content for your subscription and for analytics.
If you continue to browse Lexology, we will assume that you are happy to receive all our cookies. For further information please read our Cookie Policy.
Results 1 to 4 of 4
Most popular |Most recent


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USA - October 17 2018 On Tuesday, the Food and Drug Administration (FDA or the agency) published a draft guidance document, "Presenting Quantitative Efficacy and Risk...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FDA Issues Draft Guidance on Requirements for Public Warnings for Recalled Products

USA - January 26 2018 FDA recently released a draft guidance clarifying the regulatory requirements for public warnings in the event of a recall under the agency’s recall...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