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 […]
What’s your FDA Site Selection Score? Read More »
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 »
By Daniel R. Matlis Do you know that tense moment during the wedding ceremony, when the officiant says “speak now or forever hold your peace?”
By Daniel R. Matlis Do an internet search on Process Analytical Technology and you will be bombarded with sites for companies selling sensors, software and
Don’t forget the Process in PAT Read More »
By Daniel R. Matlis On the May 9th issue of Information Week, Mitch Wagner provides some simple and elegant solutions on his article entitled “A
RFID on Prescription Drugs Read More »
By Daniel R. Matlis If I had a penny for every time I’ve been asked this question… A company is looking for a customer complaints/ CAPA
Should I Build or Should I Buy? Read More »
By Daniel R. Matlis My friends at MRO sent me an interesting whitepaper to review entitled “Understanding the Real Risk for Asset Intensive Industries”. In
One Size Does Not Fit All Read More »
