Posts Tagged ‘FDA’
Please Send the FDA Your Comments
New Opioid Policy Steering Committee On September 29 of this year, the Food and Drug Administration (FDA) published a notice — Opioid Policy Steering Committee; Establishment of a Public Docket; Request for Comments — in the Federal Register, The Daily Journal of the United States Government. The FDA is seeking comments from members of the…
Read MoreThe Other Side of the Pain Story by guest Richard L. Martin
The Other Side of the Pain Story By Richard L. Martin, BSPharm (retired) I was a hospital pharmacist for twenty-five years. The last four years in practice, I was involved with the cancer ward helping oncologists, recommending pain medications, adjusting pain medications, and safely switching patients from one medication to another. Even though it’s been…
Read MorePreparing for an FDA Advisory Committee Meeting: What You Need to Know
Mark Twain is quoted as saying: “If I had more time, I would have written a shorter letter.” What Is an FDA ADCOM? Pharma and device companies seeking approval for their products are often required to present their data to an FDA advisory committee meeting (ADCOM). They have a limited time in which to tell…
Read MoreHere Are the Important Questions We Need to Ask About Prince’s Fentanyl Overdose
You’ve probably heard by now that a medical examiner has determined Prince, the musical superstar, died of a fentanyl overdose. While other opioids get more attention, fentanyl is the stealth bomb for abusers. Fact About Fentanyl Fentanyl is 100 times more dangerous than morphine. The dose at which fentanyl produces the pain relief that users…
Read MoreReasons Former FDA Commissioner David Kessler Misses Point of the Opioid Crisis
Dr. David A. Kessler was interviewed by Jim Axelrod of CBS News about the opioid crisis. Specifically, Axelrod asked Kessler about the increased use of opioids over the past twenty years, and how we might get the opioid epidemic “back in the bottle.” Always controversial, since the days between 1990 and 1997 when he served…
Read MoreAbuse-Deterrent Formulations Are Part of the Solution to Overdose Crisis
Curbing The Epidemic of Drug Overdoses Dr. Robert Califf, the new commissioner of the Food and Drug Administration, is focusing his energy on curbing the epidemic of drug overdoses. He told a panel of FDA advisors last week that abuse-deterrent formulations (ADFs) may be part of the solution. However, many speakers at that panel…
Read More