Managing the Chain of Custody and Identity for Regenerative Medicine Products. By: Daniel R. Matlis, President According to FDA Commissioner Scott Gottlieb, M.D. “We’re at the beginning of […]
Lot Size: YOU – When YOU are the RAW MATERIAL and the FINISHED PRODUCT Read More »
By: Giselle C. Matlis, Research Assistant On August 29, 2017 the FDA published a Safety Communication, Firmware Update to Address Cybersecurity Vulnerabilities Identified in Abbott’s
FDA confirms: Hacking a pacemaker only requires commercially available equipment Read More »
By Axendia Staff For decades, Medical Technology (Med-Tech) companies have embarked in Process Improvement initiatives to enhance product quality while reducing costs. But ask yourself
No Time to Read? Watch the 1-Minute Video Briefing Read More »
Push for growth in emerging markets like Brazil, Russia, India and China (BRIC). For some Med-Tech Companies, growth rates in emerging markets are double, triple
With Growth Rates Stagnating In Developed Markets, What Is A Med-Tech Exec To Do? Read More »
By Daniel R. Matlis In 1966 the Star Trek television series introduced us to the Medical Tricorder – a hand held device used by doctors
Qualcomm Helps Bring Star Trek Technology to Healthcare Read More »
By James McCormack PhD On February 19, 2010, FDA published a proposed rule [75 FR 7412] that, when finalized, will have a profound effect on
The Most Important Proposed FDA Rule No One Is Talking About Read More »
By Daniel R. Matlis Although Senators McCain and Obama (listed in alphabetical order) are looking to address many of the same problems, they have very
Presidential Candidates Agree on Drug Re-Importation – That is Not Fair Read More »
By Daniel R. Matlis Although Senators McCain and Obama (listed in alphabetical order) are looking to address many of the same problems, they have very
Presidential Candidates Agree on Drug Re-Importation – That is Not Fair Read More »
By Daniel R. Matlis On September 15 2008, FDA’s final rule on “Current Good Manufacturing Practice and Investigational New Drugs Intended for Use in Clinical
Please Do The Right Thing Even When No One is Looking Read More »
By Daniel R. Matlis For years I have been joking about some company marketing a sugar pill based on clinical trial data supporting the “placebo
Obecalp Is Clinically Proven More Effective Than Hugs and Kisses Read More »
By Ronald L. Trowbridge, Ph. D. Volunteer Adjunct Scholar Abigail Alliance for Better Access to Developmental Drugs In August, we (Abigail Alliance) lost our case
Life, Liberty and the Access to Promising Investigational Drugs Read More »
By Daniel R. Matlis No, it’s not what you think; I’m not going “pro” this or “anti” that on you. I am referring to the
My Body, My Choice? Read More »
