The U.S. Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) allowing distribution of two decades-old malaria drugs — Chloroquine Phosphate and Hydroxychloroquine Sulfate — to treat COVID-19. ...more
Over a year ago, HHS Secretary Alex Azar requested that FDA establish a working group to explore how drug importation “could help address price hikes and supply disruptions.” The FDA working group was not assigned the task of...more
7/23/2019
/ Biotechnology ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Food and Drug Administration (FDA) ,
Healthcare Reform ,
Imports ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Agenda ,
Regulatory Oversight ,
Regulatory Standards ,
Rulemaking Process ,
Secretary of HHS ,
Supply Chain ,
Working Groups
FDA authority to crack down on illegally marketed stem cell treatments confirmed -
On Monday, a federal District Court in Florida issued a decisive blow against US Stem Cell Clinic, LLC, granting the U.S. Food and Drug...more
6/7/2019
/ Biologics ,
Food and Drug Administration (FDA) ,
Fraudulent Marketing ,
Health Care Providers ,
Health Clinics ,
Life Sciences ,
Pharmaceutical Industry ,
PHSA ,
Regulatory Oversight ,
Regulatory Standards ,
Stem cells
On Tuesday, the Food and Drug Administration (FDA or the agency) published a draft guidance document, "Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer Promotional Labeling and Advertisements,"...more
On August 21, 2017, FDA solicited comments in the Federal Register on a new potential approach regarding communicating risk information in direct-to-consumer (DTC) broadcast ads for prescription drugs and biologics that...more