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

Search Pharmaceutical Processing
 
Search Marketplace
 
Subscribe to Pharmaceutical Processing
 


































 
Buyer's Guide – Products

Outsourcing

Clinical Services
CLINICAL PACKAGING Product News,    Companies
CLINICAL PACKAGING, material / product mgmt. Product News,    Companies
CLINICAL PACKAGING, software Product News,    Companies
CLINICAL TRIALS MANAGEMENT Product News,    Companies
CLINICAL TRIAL MATERIALS Product News,    Companies
PHASE I Product News,    Companies
PHASE II Product News,    Companies
PHASE III Product News,    Companies
PHASE IV Product News,    Companies
PRE-CLINICAL TESTING Product News,    Companies
TOXICOLOGY SERVICES Product News,    Companies
Engineering Services
CONSTRUCTION Product News,    Companies
CORROSION ENGINEERING Product News,    Companies
DESIGN Product News,    Companies
ENGINEERING Product News,    Companies
GMP AUDITS Product News,    Companies
OSHA-PROCESS SAFETY MANAGEMENT COMPLIANCE Product News,    Companies
PROCESS HAZARDS ANALYSIS Product News,    Companies
PROCUREMENT Product News,    Companies
PROJECT MANAGEMENT Product News,    Companies
SYSTEM INTEGRATION Product News,    Companies
VALIDATION Product News,    Companies
Engineering Services / Facility Type
BIOTECH FACILITIES Product News,    Companies
CLEAN ROOM Product News,    Companies
DEVELOPMENT LABS Product News,    Companies
PACKAGING FACILITIES Product News,    Companies
PILOT PLANTS Product News,    Companies
QC LABORATORIES Product News,    Companies
SHIPPING / WAREHOUSING FACILITIES Product News,    Companies
SOLID DOSAGE PLANTS Product News,    Companies
STERILE PROCESS Product News,    Companies
Laboratory Services
AUDITING Product News,    Companies
BIOAVAILABILITY / BIOEQUIVALENCY Product News,    Companies
BIOLOGICAL TESTING Product News,    Companies
CHEMICAL ANALYSIS Product News,    Companies
CHROMATOGRAPHIC ANALYSIS Product News,    Companies
DEGRADATION STUDIES Product News,    Companies
DISSOLUTION TESTING Product News,    Companies
DNA SEQUENCING Product News,    Companies
DRUG SAFETY REPORTING Product News,    Companies
ENVIRONMENTAL TESTING / MONITORING Product News,    Companies
FILTER TESTING / CERTIFICATION Product News,    Companies
GLP AUDITS Product News,    Companies
IMMUNOLOGY Product News,    Companies
IN VITRO TESTING Product News,    Companies
MATERIAL ANALYSIS Product News,    Companies
METABOLISM / PHARMACOKINETICS Product News,    Companies
METHOD DEVELOPMENT Product News,    Companies
METHOD VALIDATION Product News,    Companies
MICROBIOLOGICAL ANALYSIS / TESTING Product News,    Companies
NMR ANALYSIS Product News,    Companies
PARTICLE SIZE CLASSIFICATION Product News,    Companies
PHARMACOLOGY Product News,    Companies
PHYSICAL TESTING Product News,    Companies
PRODUCT REGISTRATION Product News,    Companies
PYROGEN / ENDOTOXIN TESTING Product News,    Companies
QUALITY ASSURANCE / QUALITY CONTROL Product News,    Companies
RAW MATERIAL TESTING Product News,    Companies
STABILITY TESTING Product News,    Companies
STERILITY TESTING Product News,    Companies
TOXICOLOGY Product News,    Companies
TRAINING Product News,    Companies
USP-NF TESTING Product News,    Companies
Manufacturing Services
AGGLOMERATION Product News,    Companies
BIOPHARMACEUTICALS Product News,    Companies
COATING Product News,    Companies
DISTILLATION Product News,    Companies
ENCAPSULATION Product News,    Companies
FERMENTATION Product News,    Companies
FLUID BED PROCESSING Product News,    Companies
GMP AUDITS Product News,    Companies
GRANULATION Product News,    Companies
LYOPHILIZATION SERVICES Product News,    Companies
MICRONIZATION Product News,    Companies
MILLING AND GRINDING Product News,    Companies
MIXING / BLENDING Product News,    Companies
NUTRACEUTICAL PRODUCTS Product News,    Companies
ORGANIC SYNTHESES Product News,    Companies
PROTEIN PURIFICATION Product News,    Companies
SCREENING / CLASSIFYING Product News,    Companies
STERILIZATION Product News,    Companies
Manufacturing Services / Specialty Products
AEROSOLS Product News,    Companies
ASEPTIC PROCESSING Product News,    Companies
BIOPHARMACEUTICALS Product News,    Companies
BULK PREPARATIONS Product News,    Companies
CLEAN ROOM SERVICES Product News,    Companies
CREAMS / OINTMENTS Product News,    Companies
INJECTABLES Product News,    Companies
MEDICAL DEVICES Product News,    Companies
ORAL DRUG DELIVERY Product News,    Companies
OTC PRODUCTS Product News,    Companies
PARENTERALS, LVP Product News,    Companies
PARENTERALS, SVP Product News,    Companies
PEPTIDES Product News,    Companies
POWDERS Product News,    Companies
PRIVATE LABEL PRODUCTS Product News,    Companies
SIZE REDUCTION SERVICES Product News,    Companies
SOFT GELATIN Product News,    Companies
SOLID DOSAGE Product News,    Companies
SOLUTIONS / SUSPENSIONS Product News,    Companies
SUPPOSITORIES Product News,    Companies
SUSTAINED-RELEASE PRODUCTS Product News,    Companies
SYRINGES, pre-filled Product News,    Companies
TABLET / CAPLET COATING Product News,    Companies
TRANSDERMALS Product News,    Companies
VETERINARY PRODUCTS Product News,    Companies
Miscellaneous Services
CALIBRATION SERVICES Product News,    Companies
ELECTROPOLISHING Product News,    Companies
EXPERT TESTIMONY Product News,    Companies
GARMENT CLEANING Product News,    Companies
HAZARDOUS WASTE DISPOSAL Product News,    Companies
INSTRUMENT REPAIR Product News,    Companies
NDA SUBMISSIONS Product News,    Companies
PASSIVATION Product News,    Companies
REGULATORY AFFAIRS Product News,    Companies
STORAGE / DISTRIBUTION Product News,    Companies
VENDOR SOURCING SERVICES Product News,    Companies
Packaging
COATING AND LAMINATING Product News,    Companies
MATERIAL ANALYSIS, BOTTLES, CARTONS, PACKAGING Product News,    Companies
Packaging Services
BAR CODING Product News,    Companies
BLISTERPACKAGING Product News,    Companies
CHILD RESISTANT PACKAGING TESTING Product News,    Companies
FORM / FILL / SEAL Product News,    Companies
LABELING Product News,    Companies
PACKAGE DESIGN Product News,    Companies
PACKAGE DEVELOPMENT Product News,    Companies
PACKAGING, for clinical trials Product News,    Companies
PACKAGING, for samples Product News,    Companies
PACKAGING, unit dosage Product News,    Companies
POUCHING Product News,    Companies
PRIVATE LABEL Product News,    Companies
Packaging Services / Specialty Products
AEROSOLS Product News,    Companies
AMPULE / VIALS Product News,    Companies
LIQUIDS Product News,    Companies
OTC PRODUCTS Product News,    Companies
PARENTERALS Product News,    Companies
POWDERS Product News,    Companies
SOLID DOSAGE Product News,    Companies
SYRINGE Product News,    Companies
UNIT DOSAGE Product News,    Companies
R&D Services
CATALYTIC PROCESS DEVELOPMENT Product News,    Companies
CHIRAL SEPARATIONS, R&D Product News,    Companies
CHROMATOGRAPHIC ANALYSIS, GC / MS Product News,    Companies
CHROMATOGRAPHIC ANALYSIS, HPLC Product News,    Companies
DRUG STABILITY STUDIES Product News,    Companies
METABOLIC ANALYSIS Product News,    Companies
PRE-CLINICAL DEVELOPMENT Product News,    Companies
PROCESS DEVELOPMENT Product News,    Companies
PRODUCT DEVELOPMENT SUPPORT Product News,    Companies
PRODUCT FORMULATION Product News,    Companies
SCALE UP SERVICES Product News,    Companies
SUSTAINED RELEASE DELIVERY Product News,    Companies
TECHNICAL WRITING Product News,    Companies
TECHNOLOGY TRANSFER Product News,    Companies
VALIDATION Product News,    Companies
Validation Services
CLINICAL Product News,    Companies
EQUIPMENT CLEANING Product News,    Companies
MANUFACTURING Product News,    Companies
MASTER PLANNING Product News,    Companies
PILOT PLANT Product News,    Companies
PROCESS VALIDATION Product News,    Companies

 
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.

Add a comment  Add a Comment  (1)

More Small Doses
Digital Library