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Welcome to the real world: FDA issues long-awaited framework for evaluating the potential use of real-world evidence to support regulatory decisions for drugs and biologics

USA - December 11 2018 On December 6, the Food and Drug Administration (FDA) published a framework for its Real-World Evidence (RWE) Program to strategically leverage...

Heidi Gertner, Robert Church, Susan S. Lee.


CMS proposes requiring drug prices in TV ads

USA - October 23 2018 On October 15, CMS released a proposed rule titled “Medicare and Medicaid Programs: Drug Pricing Transparency,” which would require direct-to-consumer...

Beth L. Roberts, Elizabeth (Beth) Halpern.


A new normal in the pharmaceutical industry: How to fight back when your competitor can't stop fibbing

USA - October 22 2018 Speaking in September at a discussion hosted by the Alliance for a Stronger FDA, Dr. Janet Woodcock provided some candid insight into FDA's...

Susan M. Cook, Heidi Gertner, David M. Fox, Susan S. Lee.


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USA - October 17 2018 On Tuesday, the Food and Drug Administration (FDA or the agency) published a draft guidance document, "Presenting Quantitative Efficacy and Risk...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


U.S. Senate passes bill requiring prescription drug ads to include prices

USA - August 28 2018 On Thursday, the U.S. Senate passed (85-7) the fiscal year 2019 minibus appropriations bill (H.R.6157) that would fund the Departments of Labor...

Heidi Gertner, Kathleen A. Peterson, Alice Valder Curran.