In its latest effort to provide direction and clarity to regulated industry and stakeholders, on September 23, the U.S. Food and Drug Administration (FDA) published a proposed rule and preamble amending its medical product...more
10/1/2020
/ Federal Food Drug and Cosmetic Act (FFDCA) ,
First Amendment ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Intended Use ,
Medical Devices ,
Off-Label Use ,
Pharmaceutical Industry ,
Preamble ,
Proposed Rules ,
Repeal ,
Totality of Circumstances Test
U.S. health officials have taken the first concrete step toward implementing the vision set out in the “American Patients First” blueprint published by President Trump and Health and Human Services (HHS) Secretary Alex Azar...more
5/13/2019
/ Advertising ,
Department of Health and Human Services (HHS) ,
Direct to Consumer Sales ,
Drug Pricing ,
First Amendment ,
Free Speech ,
Medicaid ,
Medicare ,
Pharmaceutical Industry ,
Prescription Drugs ,
Price Transparency ,
Regulatory Oversight ,
Statutory Authority ,
Television Commercials ,
Trump Administration