Monthly Publications
In Depth
Subscribe Now
In Depth
coverage of timely
Life Science
Compliance issues
Subscribe Now
Browsing Category
FDA
FDA ER-LA REMS Day 2 of the Drug Safety and Risk Management Advisory…
Day Two of the Joint Meeting of the Drug Safety and Risk Management Advisory Committee (DSaRM) and the Anesthetic and…
Exploring Strage New Worlds – FDA’s 2016 Program Alignment and…
This article provides an overview of the FDA's initiative to realign programs from location-centered structures and…
FDA ER-LA REMS Day One of Meeting of the Drug Safety and Risk Management…
The Food and Drug Administration (FDA) is hosting a two-day long Joint Meeting of the Drug Safety and Risk Management…
The FDA Shield – The Medtronic Infuse Case and the Latest Tango of…
The U.S. Supreme Court will shortly decide whether it will hear a case that will have a significant impact on the life sciences…
CME and the Opioid Crisis
Dramatic increases in death due to prescription opioid abuse has gained national attention. In the last month alone, the…
New FDA Commissioner Releases List of Priorities
Newly appointed Commissioner of Food and Drugs Robert M. Califf, M.D., recently wrote an article on his goals for the…
FDA Opinion on Proactive Response to Prescription Opioid Abuse
Opioid abuse has been in the news for the past few months, and it seems as though it will continue to be in the news for…
A Basic Geometry Lesson – FDA’s Off-label Losses
Lon - FDA's Off-label
The new decision in United States v. Vascular Solutions, Inc., provides the third point in a curve of…
Update on Patient Participation in Medical Products Discussions
When President Obama signed the Food and Drug Administration Safety and Innovation Act (FDASIA) into law in 2012, it…
FDA to Conduct Studies in Pharmaceutical Manufacturing
According to a recent report, the FDA is looking for companies to participate in a program that will review the latest…