Now on Pharmaceutical Processing
California ePedigree Push to 2015 – What does it mean? Comments
From a vision to a vial in 12 months - Process development and... Comments
Addressing the Challenges Contract Manufacturing Organizations are... Comments

Subscribe to Pharmaceutical Processing
 
































 
Other Products
Other Items from AdvantaPure

Wire-Reinforced EPDM Hose Handles Both Suction And Discharge
December 2008
Tubing Designed For High Purity Fluid Transfer
June 2008
Single-Use Process System Consists Of Tubing, Components And Other Process-Related Parts
March 2008
Stainless Steel-Overbraided PTFE Hose Available In Six Variations
February 2008
Silicone Tubing Designed For Long Life
September 2007
Read ⁄ Write RFID Tag Is Gamma-Radiation Resistant
April 2007
Process Equipment Tracking Addresses Equipment Safety And Replacement Concerns
March 2006
Molded Silicone Stoppers and Sealing Systems for Aseptic Applications
February 2006
Process Equipment Tracking Addresses Equipment Safety And Replacement Concerns
January 2006
Process Equipment Tracking System Ideal For Critical Processes
Color Silicone Tubing Provides Instant Line Identification
December 2005
Multiple Grades Of Silicone Tubing And Hose Meet A Wide Range of Applications
Sanitary Fittings Provide An Increased Level of Quality Assurance
November 2005
Class VI Thermoplastic Elastomer Material Offered As Extruded Tubing Or Injection-Molded Components
August 2005
Lightweight Suction Hose Replaces Heavy, Ply-Wrapped Rubber Hose
July 2005
Hose Identification Systems Quickly And Clearly Identify Hoses And Assemblies
May 2005
Molded Silicone Components Ideal For Various Containers
April 2005
Silicone Hose Improvements Increase Flexibility And Strength
Molded Silicone Stoppers And Sealing Systems For Aseptic Applications
March 2005
Molded Silicone Stoppers And Sealing Systems For Aseptic Applications
February 2005
Co-Extruded Plastic Tubing Offers Purity And Flexibility
December 2004
Molded Silicone Assemblies Reduce Installation Time And Improve Cleanliness
Molded Silicone Assemblies Reduce Installation Time And Improve Cleanliness
Hose Assembly Tracking System, Identifies, Records, And Stores Information
May 2004
Stainless Steel Crimp Fittings Feature All Surfaces Finished And Edges Rounded
April 2004
Sanitary Fittings Manufactured From 316L Stainless Steel
March 2004
Hose Identification
December 2003
Hose Identification
Silicone Hose Labeling System
June 2003
Butyl Rubber Hose
May 2003
Tubing And Hose
March 2003

 
Small Doses

You Can’t Fight City Hall

by Mike Auerbach, Editor
Mike Auerbach, Editor Pharmaceutical Processing

Throughout my life I’ve been to countless sporting events – from local soccer matches my kids have been involved in up to major league events in almost every sport. If there is one thing I have learned over the years it’s that you can’t win an argument with a referee. Whether it’s an overzealous parent on the sideline, a student/athlete on a high school field or a professional athlete in a big city stadium – arguing with a referee or an umpire will get you no where. Yet people continue to do so - and frankly I don’t understand why. During a sporting event – the referee is the LAW out there on the playing field – and all of his or her decisions are final - so why bother fighting city hall? And yet many people continue to try – only to find themselves being thrown out of a game; or in the case of an overzealous parent – asked to leave the sideline.

A similar situation came to light recently when a major pharmaceutical manufacturer was warned by the FDA that they were in violation of the law by marketing over-the-counter pain relievers with unproven health claims.

The agency allows traditional pain relievers to be sold over-the-counter without review, as long as they include standard directions and labeling for consumers. But the FDA said the products from the company in question overstepped those regulations by claiming that the added ingredients in each medicine help fight specific diseases.

In general, the FDA discourages firms from packaging drugs with dietary supplements because it gives the impression both have been evaluated by the FDA, when in fact, the agency only regulates drugs.

What were they thinking? Going back to my sport analogy – the FDA is the referee and they make the rules – so what did this company hope to accomplish? In this case you can't fight city hall or the FDA and the repercussions are more severe than a simple red card.

More Small Doses
Digital Library
























Bioscience Technology Chromatography Techniques Drug Discovery & Development Laboratory Equipment Pharmaceutical Processing R&D Scientific Computing
Advantage Business Media © Copyright 2008 Advantage Business Media
Privacy Policy | Terms & Conditions | Advertise With Us