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Food Processing September 2007	Regulatory Issues: Navigating the health claim maze FDA's recent guidance focuses only on the process for evaluating evidence supporting a health claim on food labels.
Prepared Foods May 4, 2007 Mark Hostetler	Claims Substantiation for Weight Management Products There is regulatory guidance available to help answer the question of how much and what kind of claims support is required.
Food Engineering February 1, 2007	Regulatory Watch FDA finds meat and milk from animal clones is as safe to eat as from conventionally bred animals.
Food Processing February 2008 David Joy	Some health claims in jeopardy FDA is re-evaluating health claims for soy, antioxidant vitamins and fat-cancer.
Prepared Foods October 1, 2006 Steven B. Steinborn	An Apple a Day...but How Big an Apple? When deciding how much of an ingredient or nutrient must be added to a product to justify its advertising claim, certain regulatory guideposts should be followed.
Food Processing August 2006 David Joy	Regulatory Issues: Opportunities and challenges of functional ingredients There is more than one way to conclude whether a functional ingredient intended for addition to food is legal.
Entrepreneur March 2005 Stephen Barlas	Just the facts The FDA doesn't want any more lies on dietary supplement labels... Is Sarbanes-Oxley a Class Act?... etc.
Bio-IT World April 15, 2003 Janet Woodcock	FDA Director Explains the Changes The head of the Center for Drug Evaluation and Research discusses why the FDA is now kinder and gentler about Part 11 compliance.
Food Processing February 2005 David Joy	Regulatory Issues: Generally recognized meaning of GRAS The GRAS exception exists so the FDA does not spend valuable resources reviewing things that clearly are safe.
Prepared Foods September 1, 2006 William A. Roberts, Jr.	Claiming a Function Functional foods can claim preventative health benefits, but be careful to not infer a cure-all food.
Pharmaceutical Executive January 1, 2006 Clinton & Wechsler	What Ever Happened to Critical Path FDA's ambitious program to improve drug development disappeared from view almost as soon as it was announced. Suddenly, it's back, but is it here to stay?
Food Processing April 2005 David Joy	Regulatory Issues: Serving up whole grains With consumers increasingly aware of the benefits of whole grains, a simple, factual label statement about their presence may suffice. But many food manufacturers want to make label claims, so the the question is: What exactly can be said about whole grains on a food label?
The Motley Fool August 18, 2011 Brian Orelli	Running the Correct Trial Isn't Enough MELA Sciences' stock is up on claim that their trial meets FDA guidance, but they still need to prove that the device actually works.
Bio-IT World September 2005 Mark D. Uehling	Murky Diary Entries The FDA is planning to clarify the degree to which existing patient diary technologies are (or are not) encroaching on data-management duties formally assigned to clinical investigators. That guidance is in the works, with no known timetable.
Food Processing March 2006 Dave Fusaro	One more step needed on grains The FDA has left it up to food marketers to decide if its guidance on whole-grain content is appropriate. And they have until April 17th to do so.
The Motley Fool March 5, 2008 Brian Orelli	FDA (Indirectly) Thwacks Amylin The FDA's draft guidance puts a cloud of uncertainty over the makers of diabetes drugs.
Bio-IT World April 15, 2003 Heller & Philbin	Part 11: The FDA's New View The FDA now has a softer perspective on enforcement, but companies will still have to watch their step.
Nutra Solutions January 9, 2008 Ginny Bank	Conquering Cardiovascular Disease Beneficial heart-healthy ingredients include dietary fiber, omega-3s and certain oils, phytosterols and soy protein.
Food Processing January 2007 David Joy	FDA considers functional foods There is no formal regulatory definition associated with the term "functional foods," but the FDA is soliciting information and comments on whether or not these foods should be regulated more strictly.
Bio-IT World April 16, 2004	Best of the Best, Sir The FDA wants to change its ways and share its accumulated wisdom as part of a focused attack on costly, unpredictable product development.
Prepared Foods August 11, 2006	Enrichment and Health Claims This article highlights several threshold legal principles that govern what nutrients may be added to which foods and at what levels.
The Motley Fool September 11, 2007 Billy Fisher	FDA Takes Issue With Boston Scientific Boston Scientific has until later this month to respond to an FDA letter prompted by the company's failure to disclose two of five deaths in a stent trial that the medical device maker abandoned in 2006. Investors take note.
Pharmaceutical Executive August 1, 2014 Jill Wechsler	Social Media Struggles Continue Tweeting limited, corrections okay, says FDA, as industry, regulators wrestle with the digital world.
Pharmaceutical Executive February 1, 2012 Jennifer Ringler	Industry Trees are Falling, But is FDA Around to Hear? Experts weigh in on FDA's long-awaited social media guidelines.
The Motley Fool August 14, 2008 Brian Orelli	Wald Equation Won't Derail Boston Scientific The Wall Street Journal reanalyzes Boston Scientific's data on its new drug-eluding stent, but will the FDA care?
Science News September 25, 2004 Janet Raloff	Omega-3's May Hit Food Labels The FDA will allow food manufacturers to make health claims for two omega-3 fatty acids, oils typically found in coldwater fish. Food labels can now note that products containing these oils might provide some protection from heart disease.
Science News April 2, 2005 Janet Raloff	Improving Prospects for Functional Foods The Institute of Food Technologists (IFT) reports the nutraceutical industry faces major roadblocks to expansion unless the federal government institutes new regulations to streamline the FDA's evaluation of candidates for this novel class of products.
Pharmaceutical Executive December 1, 2005 Jill Wechsler	Washington Report: Big Production Drug manufacturing costs too much and is cumbersome to regulate. FDA's answer: Quality by design, which shifts the emphasis from testing the final product to building quality into the manufacturing process from the beginning.
Food Processing January 2005 David Joy	Regulatory Issues: The FDA agenda for 2005 As in the past, the FDA has a full agenda of food regulatory matters in 2005. So it's not good that the FDA's scientists are demoralized and the agency stands accused of being too friendly with a regulated industry.
Pharmaceutical Executive June 1, 2014 dos Santos & Leskin	Social Media and the In-House Counsel Social media poses a regulatory and litigation maze that must be carefully navigated by pharmaceutical companies.
The Motley Fool June 15, 2007 Brian Lawler	Encysive's Date With Destiny Approaches A decision on the specialty drugmaker's lead drug is imminent. Betting against the FDA is generally not a good idea for investors. Here are statements from Encysive's past press releases about Thelin
Food Processing July 2013 Dunkiel & Boucher	Be Careful in Making Product Claims Marketing claims, especially regarding 'natural,' raise your legal risks.
Food Processing October 2008 Diane Toops	A Conversation with Food Safety Czar David W.K. Acheson A exclusive conversation with `food safety czar' David W.K. Acheson, FDA's Associate Commissioner for Foods.
Food Engineering January 6, 2008	Regulatory Watch Push for larger FDA food safety budget... Study urged on food from cloned animal...
The Motley Fool March 27, 2008 Brian Orelli	Tougher Rules Could Help Stent Makers The FDA has finally issued draft guidance on the minimum requirements that it thinks companies need to fulfill to get drug-eluting stents approved.
Food Processing February 2006 Leslie T. Krasny	Regulatory Issues: FDA Denies Petition on Whole Grain Descriptors Currently, hundreds of products are marketed with "whole grain" statements, despite ambiguity concerning the regulatory status of descriptors such as "good" and "excellent" source.
The Motley Fool August 12, 2010 Brian Orelli	Turnaround Signal, or Just Noise on the Decline? Boston Scientific clears up an FDA warning letter -- four years later.
Pharmaceutical Executive July 1, 2011 Jill Wechsler	Battles over Biosimilars Sponsors must handle interchangeability, exclusivity, cost and coverage hurdles to win biosimilars game.
The Motley Fool January 3, 2007 Stephen Albainy-Jenei	Attack of the Pod Cows The FDA has endorsed food from cloned animals. While the agency's conclusions don't exactly herald the invasion of the farm-animal snatchers, they do provide an open opportunity for companies that are well-positioned in the industry.
Food Engineering June 2, 2009	FDA Should Take Over Produce Safety Standards FDA leadership may be needed to determine sound science and make certain there is a level playing field in the industry.
Pharmaceutical Executive September 1, 2011 Richard Gliklich	The Power of Observation Observational studies present a compelling real-world corollary to the classic randomized clinical trial.
Prepared Foods July 11, 2007 Mark Hostetler	Regulations: Updating Organic An examination of "organic" labeling regulations and how to better understand them.
Pharmaceutical Executive March 1, 2012 Jill Wechsler	When Talk is Not So Cheap FDA and industry are pushing user fees, while they struggle with curbs on communications.
Food Processing April 2007 Leslie Krasny	Wellness Foods' Regulatory Issues: It's a Natural The FDA has not been active in challenging "natural" claims for foods, although "warning" letters have been sent to manufacturers, particularly for the use of color additives in products bearing "natural" claims.
The Motley Fool April 24, 2008 Brian Lawler	FDA Stings Genzyme Earnings A nasty surprise hurts the drug developer's first quarter results.
Food Processing December 2010 Diane Toops	Wellness Food Trends: Healthier Foods for the Heart Foods can be a solution (though carefully worded) for the leading cause of death.
Prepared Foods June 5, 2007 Mark Hostetler	Regulations: Corn Oil Claims The FDA approves a health claim relating to corn oil and reduced risk of heart disease and changes to irradiation regulations.
Pharmaceutical Executive May 1, 2005 Jill Wechsler	Washington Report: The Pendulum Swings FDA cracks down on safety. Haven't we been here before? Perhaps in the end, the public will have a better understanding of the dangers associated with all pharmaceuticals and how virtually impossible it is to guarantee a risk-free medical treatment.
Chemistry World February 14, 2012 Rebecca Trager	FDA proposes biosimilars approval pathway The US Food and Drug Administration has released its long awaited guidance to assist in the development and approval of so-called 'biosimilars' - biological drugs that are very similar to licensed ones.
Food Processing April 2012 Hagey et al.	How Food Processors Can Avoid 'Natural' Disasters With no federal guidance on how a product can be labeled as natural, how can companies compete while minimizing potential liability?