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The Motley Fool August 11, 2004 Charly Travers |
Utah Medical Slapped by the FDA In this suit, the FDA is seeking to bar the company from manufacturing and distributing medical devices until it complies with the FDA's Quality System regulation (QSR). This event rocked the stock, sending it down nearly 33% for the day. |
The Motley Fool December 12, 2003 Zeke Ashton |
A Big Win for the Little Guy Sometimes the little guy wins. Utah Medical Products, a little company with a history of creating shareholder value, recently won an important legal battle with Tyco International. With a big cash payment on the way, another share buyback is a strong possibility. |
The Motley Fool December 22, 2003 Alyce Lomax |
Losing Faith in Inspire Delay for its dry-eye treatment leaves investors uninspired. |
Pharmaceutical Executive November 1, 2008 Patrick Clinton |
Over There Is it the FDA's responsibility to be in charge of inspections at foreign pharmaceutical plants? |
The Motley Fool May 14, 2004 Matt Richey |
The Power of Dividends It's more than money in your pocket. Dividends create powerful and advantageous incentives. Stock buybacks have been in vogue for years, but now are frequently overused. |
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 |
Pharmaceutical Executive April 1, 2007 Patrick Clinton |
From the Editor: Taking It Outside FDA Commissioner Andy von Eschenbach said something pretty reasonable, and in return received a blistering, menacing letter from Senator Charles Grassley -- a letter that showed yet again that Grassley just doesn't understand what he's destroying in his campaign against FDA. |
The Motley Fool December 28, 2010 Brian Orelli |
Double-Digit Increase! Haven't We Learned Anything? MannKind's investors need a history lesson. |
The Motley Fool April 17, 2007 Brian Lawler |
Neurochem Must Wait The FDA delays a regulatory decision on Neurochem's lead compound. Investors, take note. |
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. |
The Motley Fool August 12, 2008 Brian Lawler |
The FDA Stands Up Cardiome What does the approvable letter mean for Cardiome and other drug developers? |
The Motley Fool May 9, 2007 Brian Lawler |
Diagnosing Dendreon Postmortem The FDA issues an approvable letter for Dendreon's top compound. Investors, take note. |
The Motley Fool May 31, 2011 Brian Orelli |
Pay Attention, Biotech Investors Competitors and partners can't be ignored. |
The Motley Fool February 23, 2004 Brian Gorman |
Abbott Cleans Up Its Act Abbott closes the books on its problems with the FDA and clears the way to a spinoff. Abbott finally passed FDA muster with its Illinois diagnostics plant. Its multi-year problem highlights the importance of investors monitoring manufacturing while watching a pharmaceutical company's pipeline. And with its FDA compliance issues behind it, Abbott can look forward to spinning off its Hospital Products Division. |
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 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 February 2011 David Joy |
7 Things You Should Know About The New Food Safety Law Considered a win for consumers, the new law will have varying effects on food & beverage processors. |
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? |
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. |
BusinessWeek June 24, 2010 Miles et al. |
Altria vs. the FDA: More than a Mild Dispute Federal regulators want the tobacco company to hand over the research behind the selling of Marlboro Golds |
The Motley Fool March 19, 2007 Brian Lawler |
Is Dendreon Doomed? A pivotal FDA regulatory meeting approaches for the development-stage pharma. Investors, take note. |
The Motley Fool November 29, 2010 Brian Orelli |
There's Still Only One Merck KGaA's oral MS drug delay is Novartis' gain. |
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 January 14, 2008 Brian Lawler |
Score One for Dendreon and Disclosure A prestigious journal supports Dendreon's potential prostate cancer treatment, and makes a compelling case for more FDA disclosure. |
The Motley Fool May 20, 2010 Brian Orelli |
FDA Transparency! A Big Win for Investors The Food and Drug Administration has possibly just made things easier for investors. Let's just hope drug companies don't shoot it down. |
The Motley Fool March 3, 2009 Brian Orelli |
A Tale of 2 Weeks It's been a busy two weeks at Genzyme as two nasty notes from the FDA follow two approvals. |
The Motley Fool April 5, 2010 Brian Orelli |
1 Month to Go! Is Dendreon a Buy? Only if you understand the risks. |
The Motley Fool February 27, 2007 Brian Lawler |
FDA Keeps Novartis Waiting The pharmaceutical experiences a regulatory setback in the U.S. for one of its top drug candidates. Investors, take note. |
Pharmaceutical Executive December 1, 2006 Richard A. Epstein |
FDA vs. the Individual In this excerpt from his important new book Overdose, an ever controversial legal scholar argues that the current system overvalues risk, ignores individual differences, and deprives patients of valuable treatments. |
The Motley Fool January 16, 2008 Brian Orelli |
Headache Almost Over for Pozen The drug is safe; hopefully that's all the FDA wanted to know. |
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 |
The Motley Fool January 22, 2008 Brian Lawler |
Adolor Under the FDA's Spotlight The FDA releases its documents on Adolor's lead drug, with surprising good news in advance of an advisory panel discussion. Investors, take note. |
The Motley Fool February 21, 2008 Brian Lawler |
A Bit of Irony From the FDA The agency has a mixed message on drug importation, as evidenced in the recent possible contamination of China-produced Heparin. |
The Motley Fool November 3, 2009 Brian Orelli |
A Little Distracted, Are You, Merck? The FDA rejects its latest application. |
Food Engineering January 1, 2009 |
Regulatory Watch: Improved FDA plan for food protection Under increasing criticism for its oversight of the nation's food supply, FDA issued a plan to better protect food from accidental and intentional contamination. |
The Motley Fool August 9, 2010 Brian Orelli |
Dendreon's in Trouble Provided you call a slap on the wrist from the FDA "trouble." |
The Motley Fool January 28, 2011 Brian Orelli |
Value Investing, Biotech Style Biotech investors should regard every binary event as a varying degree of confidence in a positive or negative result. |
The Motley Fool June 21, 2007 Brian Lawler |
Pfizer Gets Held Up The FDA issues an approvable letter for its novel HIV compound. Investors, take note. |
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. |
Food Engineering June 1, 2009 |
Regulatory Watch While food and beverage concerns have dominated the government's battle on childhood obesity, the food industry is attempting to shift the focus to fitness. |
The Motley Fool January 14, 2005 W.D. Crotty |
An FDA OK That Hurts EPIX Pharmaceuticals gets a qualified "yes" from the FDA, sending its stock tumbling. |
The Motley Fool June 29, 2004 Charly Travers |
Antegren Gets Priority Review The FDA steps up the drug's time line for approval. |
The Motley Fool February 8, 2005 |
Why Share Buybacks Matter Should you think favorably of a company buying back shares of its own stock? In many cases, yes. |
The Motley Fool November 8, 2006 Brian Lawler |
Stumbling Block for Adolor Another approvable letter from the FDA means investors may have to be patient. |
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 Processing June 2009 Dave Fusaro |
Do They Want Healthier Food or Not? Cheerios may have gone too far, but a `new' FDA should focus on safety and health. |
Chemistry World July 2007 Victoria Gill |
Conflict of interest? The FDA has been questioned after a published study brought exposed cardiovascular risks associated with GlaxoSmithKline's diabetes drug, Avandia. |
Food Processing June 2013 Bert Slonim |
Caffeine Under Siege by the FDA FDA investigation could be just the beginning of regulatory and litigation battles. |
The Motley Fool September 8, 2008 Rich Duprey |
The Coming Great Pharma Panic The FDA's drug warning list provides dangerously little information. |
The Motley Fool March 7, 2005 Brian Gorman |
Glaxo in Hot Water Glaxo's problems with the FDA could have been avoided. Investors can only hope that the FDA is in a forgiving mood. |