FDA Issues Final cGMP Guidance
By Daniel R. Matlis Yesterday, on the heels of the release of a critical Institute of Medicine Report, the FDA issued a Final Guidance …
FDA Drug Safety System Needs Fixing, IOM Report Says
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, …
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ImClone Loses Patent Decision for Cancer Drug Erbitux
By Leslie Gladstone Restaino, Esq. ImClone Systems, Inc. is reeling from a court decision Monday invalidating ownership of a significant patent for the company’s cancer …
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Compounding Redux
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 …
FDA Approves First Implantable Replacement Heart
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 …
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What’s More Sterile: the Band-Aid on Your Paper cut or Cardioplegia?
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 »
What’s More Sterile: the Band-Aid on Your Paper cut or Cardioplegia?
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 »
The impact of IBM’s Acquisition of MRO Software on the Life-Sciences Market
On August 3, 2006 MRO Software announced that it has agreed to be acquired by IBM. So, what the impact on Life-Sciences Customers? I think …
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Can I make your pacemaker software run faster?
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 …
Doctors Don’t Treat Populations, They Treat Individual Patients
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 …
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"Medicine is for the People, not for the Profits."
During my senior year, I was lucky to have a few job offers to evaluate. The top two were from Johnson & Johnson and Exxon. …
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I Lost the Cure for the Common Cold!
By Daniel R. Matlis It’s 3:00 AM and your newborn baby wakes up crying. You want to go back to sleep, but his circadian rhythm …