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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. |
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. |
Pharmaceutical Executive September 1, 2005 Jill Wechsler |
Washington Report: Crawford Steps Up As FDA's new commissioner takes the reins, his key challenge is restoring trust in the agency. |
Pharmaceutical Executive February 1, 2011 Jill Wechsler |
Challenges, Changes, Commitments The Three Cs could be taxing on FDA resources as the new Congress brings stiffer oversight and leadership revisions to the agency |
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. |
Pharmaceutical Executive April 1, 2006 Jill Wechsler |
Washington Report: A Warning Trend Washington's new answer to drug safety concerns is more warnings and more disclosure of undigested data. But warnings can go too far. Haven't FDA's critics ever heard the story of the boy who cried wolf? |
Pharmaceutical Executive January 1, 2006 Kenneth I. Kaitin |
Opinion: Memo to von Eschenbach FDA's acting commissioner has an opportunity to clarify a lot of misconceptions about the agency's role in regulating drug safety. His first order of business should be to explain exactly what FDA doesn't do. |
Pharmaceutical Executive June 1, 2009 Jill Wechsler |
A Bigger, Bolder Agency FDA is seeking more resources to support compliance and oversight. |
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 December 31, 2007 Brian Lawler |
Does Leadership Count at the FDA? Let's take a look at how drug approval rates have fared under different FDA commissioners. |
Pharmaceutical Executive January 1, 2009 Jill Wechsler |
FDA Turnaround Time Will more resources and new leadership fix FDA, or is a major overhaul in order? |
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? |
HBS Working Knowledge November 17, 2003 Martha Lagace |
The Politics of Innovation Mark B. McClellan, the new commissioner of the Food and Drug Administration, described what the FDA is doing to bridge the gap between the high cost of innovation and patients' demand for lower prices. |
Food Engineering June 4, 2007 |
Congress to beef up inspection activities With one food recall after another making headlines, Congress appears intent on beefing up federal government food inspection activities. |
Prepared Foods July 22, 2007 Mark Hostetler |
Promoting Safe and Nutritious Congress, the FDA and USDA have created a changing regulatory environment for food marketers. |
Food Processing April 2007 |
Wellness Foods HealthBites: April What's happening in the world of nutrition and health. |
Salon.com October 31, 2002 Arianna Huffington |
Drugging our children the legal way America's legal drug pushers are free to offer kids their potent concoctions without having to prove they're safe or effective. |
Bio-IT World August 13, 2003 Brian Reid |
Remaking the FDA New commissioner is pushing for greater use of technology and innovation to speed the flow of drugs to market. |
Salon.com June 7, 2000 Shannon Brownlee |
Swallowing ephedra The wildly popular herbal diet aid can be dangerous for some people. But don't expect the FDA to crack down. |
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. |
Food Processing February 2008 David Joy |
Some health claims in jeopardy FDA is re-evaluating health claims for soy, antioxidant vitamins and fat-cancer. |
Pharmaceutical Executive December 1, 2011 Jill Wechsler |
FDA Gets a New Look Agency expansion and globalization promote innovation, collaboration, and organizational changes |
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 September 9, 2010 Brian Orelli |
Will These Drugs Get Past the FDA This Month? See what the FDA has on its decision calendar for the rest of September. |
The Motley Fool December 31, 2010 Brian Orelli |
2010 FDA Approvals and a Look Ahead Recent history can help us handicap FDA decisions. |
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. |
BusinessWeek May 21, 2007 John Carey |
A Shot At Making Drugs Safer Congress could revamp the cozy ties between drugmakers and the FDA. Will it? |
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. |
American Family Physician December 1, 2000 William M. Rados |
Online Information for Health Care Professionals The home page of the U.S. Food and Drug Administration has undergone a major revision. The agency's Web site, which includes more than 100,000 documents, is now easier to search and covers the full scope of the FDA's activities... |
Pharmaceutical Executive December 1, 2010 Ansis Helmanis |
A New Twist in the Cost Curve The strict regulatory divide between market authorization and price reimbursement is crumbling in the US. Is industry prepared to adapt or challenge? |
Science News August 10, 2002 Janet Raloff |
Diet Pills: It's Still Buyer Beware On the dangers and uncertainties associated with non-prescription diet pills |
The Motley Fool April 11, 2008 Brian Lawler |
Amgen's Unsurprising Delay The FDA extends its review of an Amgen drug candidate. |
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. |
The Motley Fool July 30, 2010 Brian Orelli |
A Faster Pathway to Drug Approvals A thinktank called the Pacific Research Institute has proposed letting drugs approved by the European Medicines Authority onto the market in the U.S. before the Food and Drug Administration has approved the drugs. |
Pharmaceutical Executive April 1, 2009 Patrick Clinton |
Dear Commissioner... Unsolicited advice for FDA's next leader: Keep it real, fight popular delusions, and somehow, please, defend the agency. |
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. |
CIO March 15, 2006 Allan Holmes |
Rx for Risk As it revamps its workflow processes, the FDA is relying on technology to reduce the risk that unsafe substances will get into the market. |
Pharmaceutical Executive July 3, 2007 Louis A. Morris |
Culture Shock The withdrawal of Vioxx signaled a sea change. Welcome to the Culture of Drug Safety. The FDA is making changes in the way it reviews drug safety. Post-marketing staff has been enlarged 25%, and new, tougher laws are on the way. |
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. |
IndustryWeek October 19, 2011 |
FDA: A Future Innovation Partner? Could the Food and Drug Administration reform itself to help manufacturers create new medical technologies? |
Pharmaceutical Executive September 1, 2006 Jill Wechsler |
Pharm Exec Q&A: A Soft Spot for Whistleblowers FDA's most aggressive critic in Washington is Iowa Senator Charles Grassley. In this exclusive interview, he explains where the agency goes wrong and what he would do to fix it. |
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. |
Pharmaceutical Executive March 1, 2012 Ron Cohen |
FDA's Necessary Dose of Reality There's no fast-acting salve, but there are several steps that can be taken to streamline many of the procedures at FDA. And it begins with leadership. |
Pharmaceutical Executive January 1, 2007 Jill Wechsler |
Washington Report: A Full Plate It's going to be a busy year in Washington for the pharmaceutical industry. Drug safety, unapproved uses, e-data requirements, and a shift to personalized medicine are just a few of the hot issues on tap for 2007. |
The Motley Fool February 16, 2010 Brian Orelli |
For Blockbuster Cancer Drugs, Approvals Are the Easy Part Don't get too excited. As an investor, you can lower your risk by investing in cancer drug companies after a clinical trial success but before an FDA approval, but you'll also reduce your reward. |
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. |
AskMen.com October 30, 2015 Asandra & Palubicki |
Are Erectile Dysfunction Supplements Dangerous? Here's why erectile dysfunction supplements can be extremely dangerous. |
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. |
The Motley Fool October 19, 2010 Brian Orelli |
Why the FDA Won't Approve Lorcaserin and Qnexa (Yet) Obesity drugs get their day in front of the agency. |
The Motley Fool December 31, 2007 Brian Lawler |
The Anatomy Of An Approved Drug An independent audit by the FDA provides a useful summary of the characteristics of drugs approved by the agency. |