Last month, the U.S. Food and Drug Administration (FDA) issued a final guidance on drug and biologic submissions to the agency that include real-world data (RWD) and real-world evidence (RWE). The procedural guidance aims to...more
On November 20, 2020, the Department of Health and Human Services (HHS) announced it was terminating the U.S. Food and Drug Administration's (FDA) Unapproved Drugs Initiative (UDI), which is further described in...more
On November 16, 2020, the Office of Inspector General (OIG) issued a Special Fraud Alert (the Alert) regarding speaker programs hosted by pharmaceutical and medical device companies. Speaker programs are company-sponsored...more
On November 17, 2020, nine months after the start of the COVID-19 pandemic, the U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) to Lucira Health for the first COVID-19 diagnostic test for...more
On March 26, 2020, the U.S. Food and Drug Administration (FDA) issued guidance surrounding the use of 3D printing on medical devices, accessories, components, and parts during the COVID-19 pandemic....more
4/2/2020
/ 3D Printing ,
Coronavirus/COVID-19 ,
Emergency Use Authorization (EUA) ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Healthcare ,
Medical Devices ,
Medical Supplies ,
Personal Protective Equipment ,
Pharmaceutical Industry ,
Prescription Drugs