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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...

Robert Church, Meredith Manning, Susan S. Lee.


12 Years Later: Court Prohibits Marketing of Prescription Versions of OTC Drug

USA - November 5 2018 In a big win for the Food and Drug Administration (FDA), the D.C. Circuit of the United States Court of Appeals reinforced FDA’s position on what...

Bert Lao, David Horowitz.


FDA aims to harmonize its human subject protection regulations with Common Rule

USA - October 29 2018 On October 12, FDA published guidance for sponsors, investigators, and IRBs titled “Impact of Certain Provisions of the Revised Common Rule on...

Robert Church, William F. Ferreira.


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, Meredith Manning, David M. Fox, 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...

Kathleen A. Peterson, Meredith Manning, Alice Valder Curran.