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FDA
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…
FDA: Biosimilars Labeling Guidance
After several delays the FDA has finally released its draft guidance that says a biosimilar's label does not have to be…
Update on Biosimilars US Regulation 1st Quarter 2016
Yesterday the FDA approved Inflectra the Pfizer/Celltrion version of Remicade, becoming the second biosimilar and the…
FDA Announces Labeling Changes for Immediate Release Opioid Medications
The United States Food and Drug Administration has announced new required class-wide safety labeling changes for…
FDA National Direct to Consumer Advertising Survey – Again
If at first you don't succeed try, try again. That seems to be the theme of a recent announcement by the Food and Drug…