Monday, September 24, 2007

Drug or Sanitizer? A Fine Line is Drawn by FDA - Sept 24, 2007

Proctor & Gamble received a Warning Letter from FDA recently because of the way they labeled and were promoting a new foaming hand sanitizer. FDA dug into the details, including what P&G was saying on their web site about the product, and determined that the product as defined by P&G is a drug.

This Warning Letter is an interesting case study of the depth the FDA goes into in their investigations. Read the Warning Letter and forward it to your Marketing group. Go to:
www.gmptrainingsystems.com/asp/resources.asp
Click on Timely Resource Articles and scroll down.

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1259 clients since 1996


Next GMP Boot Camp Nov 14 - 15
Anaheim/Newport Beach, CA
www.gmptrainingsystems.com/asp/public_workshops.asp

See our Web Seminar schedule:
Eleven terrific programs currently scheduled plus archived programs available on CD.
www.gmptrainingsystems.com/asp/lcgc_archives.asp

Please forward this post to others in your organization who might benefit.

Monday, September 17, 2007

Mayo Clinic Conference - Sept 17, 2007

The Founder and President of GMP Training Systems, Inc., David Markovitz, will be sharing the platform with FDA Commissioner Andrew von Eschenbach, MD at the Mayo Clinic Clinical Research Conference in Minneapolis, MN this week. von Eschenbach's talk is on "Individualized Medicine." Markovitz' talk is titled "How to Optimize a System to Maximize Productivity in Clinical Research."

Learn more about this conference here:
www.mayocts.com/research/agenda.html

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1253 clients since 1996


Next GMP Boot Camp Sept 26 - 27
Anaheim/Newport Beach, CA
www.gmptrainingsystems.com/asp/public_workshops.asp

See our Web Seminar schedule:
Fourteen terrific programs currently scheduled
www.gmptrainingsystems.com/asp/lcgc_archives.asp

Please forward this post to others in your organization who might benefit.

Tuesday, September 04, 2007

Dietary Supplement or Drug: FDA decides - September 4, 2007

Sometimes the difference between a Drug and a Dietary Supplement is in the dosage. Read this excerpt from a recent Warning Letter.

You promote Cholestrix as a dietary supplement. Your website states, "Sunburst's Cholestrix is made from a specially concentrated red yeast rice extract which is standardized to contain 1.35% of naturally occurring lovastatin. Just 2 capsules per day provide 10mg. of natural lovastatin." Lovastatin is the active pharmaceutical ingredient in Mevacor and its generic counterparts, which are FDA-approved drugs to treat patients with primary hypercholesterolemia.

Traditional red yeast rice does not contain more than trace amounts of lovastatin, if any. Because Cholestrix contains red yeast rice with enhanced or added lovastatin, and bears a claim about the "powerful cholesterol fighting" benefits supplied by this ingredient, it cannot be marketed as a dietary supplement.

Read the entire Warning Letter and a similar Warning Letter issued by FDA last month to Swanson Health Products Inc. and Sunburst Biorganics. Go to:
www.gmptrainingsystems.com/asp/resources.asp
Click on Timely Resource Articles and scroll down.

GMP Training Systems, Inc.
www.GMPTrainingSystems.com
Serving 1248 clients since 1996


Next GMP Boot Camp Sept 26 - 27
Anaheim/Newport Beach, CA
www.gmptrainingsystems.com/asp/public_workshops.asp

See our Web Seminar schedule:
Fourteen terrific programs currently scheduled
www.gmptrainingsystems.com/asp/lcgc_archives.asp

Please forward this post to others in your organization who might benefit.