The draft guidances create a grey area between “on-label” and “off-label” communications that will require careful navigation as manufacturers develop HCEI analyses and promotional communications....more
1/31/2017
/ Comment Period ,
Draft Guidance ,
First Amendment ,
Food and Drug Administration (FDA) ,
HCEI ,
Health Care Providers ,
Healthcare ,
Labeling ,
Manufacturers ,
Medical Devices ,
Off-Label Use ,
Payor Contracts ,
Pharmaceutical Industry ,
Prescription Drugs ,
Product Labels ,
Public Health ,
Required Communications