Medical Product Communications Consistent With FDA-Required Labeling Draft Guidance: Navigating the Gray Zone
By Nikki Foeller -
Published 25 October 2017
This article discusses the changing landscape for promotional review regarding the shift in evidentiary standards introduced in the 2017 Consistent with the Label Draft Guidance. It also highlights industry perspectives for consideration to companies looking to apply the principles outlined in the Draft Guidance or in preview to what could be addressed in a future revision.
Categories: Features, US, FDA, Communication, Drugs
Tags: Labeling, Medical Product Communications
Medical Product Communications: Industry Seeks to Reform FDA Draft Guidances
By Zachary Brennan -
Published 21 April 2017
With a flood of new comments, pharmaceutical, biotech and medical device companies are seeking changes to two draft guidances explaining the US Food and Drug Administration's (FDA) evolving policies on industry communications with payers and claims that adhere to a drug's label.
Categories: News, US, FDA, Biologics and biotechnology, Drugs, Government affairs, In vitro diagnostics, Labeling, Medical Devices
Tags: medical product communications, off-label promotion, payer communications