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Prepared Foods October 2007 Mark Hostetler	Article: Regulations: Scientific Health Claims Review FDA's draft guidance on evidence-based health claims is aimed to help producers evaluate and understand the strength of evidence in supporting health claims.
Food Processing February 2008 David Joy	Some health claims in jeopardy FDA is re-evaluating health claims for soy, antioxidant vitamins and fat-cancer.
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?
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 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.
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.
Prepared Foods January 1, 2006	FDA and Tomato Benefit Claims Federal regulators have cleared the way for food companies to cite certain cancer benefits by tomatoes in ads and on food labels, but excluded tomato-based dietary supplements.
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.
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.
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.
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.
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.
Pharmaceutical Executive July 1, 2011 Jill Wechsler	Battles over Biosimilars Sponsors must handle interchangeability, exclusivity, cost and coverage hurdles to win biosimilars game.
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.
Food Processing March 2005 David Joy	Regulatory Issues: Regulatory impact of the new guidelines The federal government's recently issued 2005 Dietary Guidelines for Americans are primarily aimed at influencing the way Americans eat and exercise. But will the new recommendations also affect FDA's food labeling regulations?
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.
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.
Pharmaceutical Executive March 1, 2006 Jill Wechsler	Washington Report: Labels and Liability New FDA guidance aims at better communication of risks. But it creates some, too.
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 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.
Pharmaceutical Executive August 1, 2012 Jill Wechsler	Fleshing Out FDASIA Medical apps, e-submissions, counterfeit drugs, and imports tucked into fairly "clean" user-fee renewal legislation. In late June leading legislators reached across party lines to quickly approve the Food and Drug Administration Safety and Innovation Act.
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 Engineering February 1, 2007	Regulatory Watch FDA finds meat and milk from animal clones is as safe to eat as from conventionally bred animals.
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 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 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.
Food Processing July 2013 Dunkiel & Boucher	Be Careful in Making Product Claims Marketing claims, especially regarding 'natural,' raise your legal risks.
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 November 2007 David Joy	Regulatory Issues: New rules on reporting contamination Manufacturers will not have the option of handing recalls quietly. Information may even appear on FDA's web site.
Chemistry World January 21, 2010 Rebecca Renner	FDA shifts on BPA safety The US Food and Drug Administration has revised its position on the possible developmental health risks from bisphenol A, the controversial and widely used ingredient in hard plastic bottles and food packaging that it declared safe in 2008.
IndustryWeek October 19, 2011	FDA: A Future Innovation Partner? Could the Food and Drug Administration reform itself to help manufacturers create new medical technologies?
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.
The Motley Fool February 7, 2006 Stephen D. Simpson	Boston Scientific's Big Task The company won the battle for Guidant, but the hard work hasn't even begun. Value is value, and if Boston Scientific proves it can handle the considerable challenges ahead, this could ultimately be a very interesting stock again.
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 Engineering April 3, 2009	FDA offers new salmonella guidance FDA has released a guidance entitled, Measures to Address the Risk for Contamination by Salmonella Species in Food Containing a Peanut-Derived Product as an Ingredient.
Prepared Foods January 1, 2006 William A. Roberts, Jr.	Dressing Down Now that low-carb introductions are on the downswing, manufacturers of dressings, marinades and sauces are finding new ways to attract interest.
The Motley Fool February 28, 2008 Brian Lawler	FDA's Mixed Signals for Theravance The FDA gives Theravance frustrating double messages about a lead drug.
Food Processing July 2005 David Joy	Regulatory Issues: What's in a name? The Food and Drug Administration and the U.S. Dept. of Agriculture recently published a joint proposal to amend their regulations dealing with food "standards of identity."
Pharmaceutical Executive June 1, 2012 Jill Wechsler	Innovation and Collaboration A rash of "pro-innovative" approaches for testing and regulating medical products offer ways to speed more new products to market.
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.
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.
Food Processing March 2013 Biderman & Young	How Food and Beverage Manufacturers Can Avoid Class Action Litigation The recent suits against energy drink makers are lessons for all food and beverage processors.
Pharmaceutical Executive October 1, 2006 George Koroneos	Pharm Exec Q&A: Inside View The Union of Concerned Scientists made revelations about the FDA's own scientific culture. Here, Francesca Grifo, director of scientific integrity program at UCS, talks about the findings.
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.
Food Processing August 2013 Eric Lindstrom	FDA Paints Itself Into a Corner with FSMA A federal judge orders the agency to issue overdue food safety rules by November ... which looks unrealistic.
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.
Food Processing June 2013 Bert Slonim	Caffeine Under Siege by the FDA FDA investigation could be just the beginning of regulatory and litigation battles.
Bio-IT World April 2007 John Russell	Whatever Happened to the Critical Path? Science progresses at its own rate and medical science is necessarily more cautious than other branches. But it feels like the lack of money and mindshare are turning the FDA's Critical Path Initiative into just another umbrella project.
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.
Food Processing May 2006 David Joy	Regulatory Issues: FDA may cut food-contact program The agency's proposed budget may mean an end to the efficient and speedy Food Contact Notification Program -- and two- to five-year waits for reviews.