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Benefits of Being a Vagabond -- You get to Read Other People's Newspapers
Jim Lassiter -- Good News/Bad News By Jim Lassiter on 5/14/2008 10:45 AM
When you get free newspapers delivered to your door -- you tend to read them. In the May 14 edition of the New York Times an article appeared summarizing the continuing issues with getting money to the FDA and how a bunch is apparently on its way.
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WHO NEEDS COMPETITION ANYWAY?
Marc Ullman FYI Blog By marc on 5/9/2008 2:03 PM
On May 2nd, a United States District Court judge certified a class action against Glaxo Smith Klein (“GSK”). That case has something in common with GSK’s recent Citizen’s Petition aimed at forcing weight loss dietary supplements of the market.
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Havoc looms in patent and trademark law
Marc Ullman FYI Blog By marc on 5/6/2008 1:59 PM
An article in this morning's New York Times suggested that almost every patent decision (the same issue applies to trademark disputes) that had been in dispute at the US Patent and Trademark Office may be unconstitutional. It seems that a minor change in the law in 1999 may wreak havoc with your intellectual property.
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It Isn't Paranoia if They Really Are Out To Get You
Jim Lassiter -- Good News/Bad News By Jim Lassiter on 5/2/2008 12:52 PM
The latest evidence from the actions of a pharma company should give one pause. There is a legitimate danger ahead and we need to be more than naïve about the future. If you think restrictions on weight loss claims would be bad -- what about restrictions on CALCIUM claims?
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A Suitcase Nuke from Big Pharma -- Just In Time for Spring
Jim Lassiter -- Good News/Bad News By Jim Lassiter on 4/25/2008 3:13 PM
One of the members of the entity we like to call "Big Pharma" just sent a citizen's petition to FDA. This has the potential affect roughly the size of a small nuclear device on this industry. Want to find out more? Read on.
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Antioxidants and Mortality
Len Monheit Off The Cuff By len on 4/18/2008 9:42 AM
From a trickle to a flow, the latest UK-generated anaklysis, published by the Cohrane collaboration, has generated widespread headlines around the globe as the 'researchers' 'selected' several studies to examine the relationship between antioxidant supplements and prevention of mortality.
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These Remarks Were Taken IN Context
Jim Lassiter -- Good News/Bad News By Jim Lassiter on 4/15/2008 10:21 AM
The Commissioner of the Food and Drug Administration just initiated a kind of weekly Blog within the FDA Website. You really ought to see what his first posting said. Or you can read the summary here.
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Regulations and regulators
Len Monheit Off The Cuff By len on 4/7/2008 9:45 AM
OK- I'm a hypocrite and I admit it. And to those of you chastising me for being so delinquent on my blog - thanks and good on you. I'd use the excuse that I blog weekly in my editorial, but we all know that's not the same thing....or style...or purpose. Today - regulations and regulators.
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WHAT’S THE WORST THING THAT WILL HAPPEN TO ME, A WARNING LETTER?
Marc Ullman FYI Blog By marc on 2/29/2008 3:50 PM
A common misconception seems to be that the strongest regulatory action the Food and Drug Administration will take against companies that market dietary supplements with blatant drug claims will be to issue a Warning Letter. A 33-count indictment handed down by a federal grand jury this week suggests otherwise.
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Last Words on Words
Jim Lassiter -- Good News/Bad News By Jim Lassiter on 2/29/2008 12:33 PM
This last is a series of three spews about words and the impact they have on our industry points to some other definitional issues we, as an industry, would have if we were paying attention.
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IF YOU WANT TO MARKET A NEW INGREDIENT OR TRANSITION FROM SUPPLEMENT TO FOOD, THERE’S SOMETHING YOU NEED TO KNOW
Marc Ullman FYI Blog By marc on 2/28/2008 3:00 PM
On September 27, 2007 President Bush signed into law the Food and Drug Administration Amendments Act of 2007 (FDAAA). Ostensibly designed to strengthen FDA’s authority over a variety of regulated areas such as food safety and post-market surveillance of drug products, the law contains a provision that has the potential to greatly restrict the entry crossover of dietary supplement ingredients to food and the introduction of dietary supplement ingredients into the marketplace.
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The Other Edge of the Sword
Jim Lassiter -- Good News/Bad News By Jim Lassiter on 1/17/2008 2:20 PM
This is the second of three installments concerning words, language, identification and how these simple tools affect our industry, the direction it is headed and current situations involving our industry.
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