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USA - October 17 2018 On Tuesday, the Food and Drug Administration (FDA or the agency) published a draft guidance document, "Presenting Quantitative Efficacy and Risk...

Carlo Felizardo, Cailin Lechner, Meredith Manning, Susan S. Lee.


FDA guidances promote greater communication to payors about medical product value, clarify CFL communications

USA - June 14 2018 On June 12 the U.S. Food and Drug Administration (FDA or the Agency) finalized two guidance documents regarding the types of information that drug and...

Jodi Scott, Arthur E. Kim, Heidi Gertner, Jennifer Agraz Henderson, Danielle C. Humphrey, Suzanne Levy Friedman, Yetunde Oni, Meredith Manning, Susan S. Lee.


A new right for American patients: The Right to Try

USA - May 25 2018 On May 22, 2018, the U.S. House of Representatives passed Senate Bill 204, commonly known as the "Right to Try Act of 2017" by a vote of 250-169. The...

Robert Church.