By Daniel R. Matlis According to a report issued by the Institute of Medicine (IOM), the FDA suffers from a lack of clear regulatory authority, …
FDA Drug Safety System Needs Fixing, IOM Report Says Read More »
By Daniel R. Matlis Recently, I wrote an article calling for consistent federal regulatory requirements for the practice of compounding. Last month, the US District …
The U.S. Food and Drug Administration (FDA) yesterday approved the AbioCor®, the world’s first completely self-contained, implantable Replacement Heart. This approval provides patients suffering from …
FDA Approves First Implantable Replacement Heart Read More »
By Daniel R. Matlis It’s a trick question. Technically both should be sterile. But you would think that cardioplegia, the solution used to stop the …
What’s More Sterile: the Band-Aid on Your Paper cut or Cardioplegia? Read More »
By Daniel R. Matlis It’s a trick question. Technically both should be sterile. But you would think that cardioplegia, the solution used to stop the …
What’s More Sterile: the Band-Aid on Your Paper cut or Cardioplegia? Read More »
I recently read an article on the Free Software Foundation’s Website entitled “Regulatory compliance is no reason to lock up users” The author states that …
This week, Scott Gottlieb, MD Deputy Commissioner for Medical and Scientific Affairs at the Food and Drug Administration made an interesting speech before the 2006 …
Doctors Don’t Treat Populations, They Treat Individual Patients Read More »
By Daniel R. Matlis According to the Food, Drug, and Cosmetic Act, FDA statutorily required to inspect domestic drug manufacturing establishments at least once every …
By Daniel R. Matlis In the past few years, CDER has made significant changes to advance and facilitate the review of electronic regulatory submissions. These …
Efficiency, Effectiveness and FDA All In The Same Sentence? Read More »
By Daniel R. Matlis “This is a Challenging time for the FDA and the Industry” said Janet Woodcock, MD, FDA’s Deputy Commissioner of Operations and …
FDA Must Become An Information Provider As Well As A Regulator Read More »
By Daniel R. Matlis The American Medical Association’s new policy on Direct to Consumer Advertising includes imposing a temporary moratorium on newly approved drugs and …
AMA Calls For Moratorium On Advertising Of Prescription Drugs And Devices Read More »
by Daniel R. Matlis In a long awaited move, the FDA announced on Friday June 9th, that it will fully implement regulations related to the …
FDA Task Force Report Recommends e-Pedigree in Distribution and Addresses RFID Issues Read More »
