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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. mark for My Articles similar articles
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. mark for My Articles similar articles
The Motley Fool
December 22, 2003
Alyce Lomax
Losing Faith in Inspire Delay for its dry-eye treatment leaves investors uninspired. mark for My Articles similar articles
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? mark for My Articles similar articles
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. mark for My Articles similar articles
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 mark for My Articles similar articles
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. mark for My Articles similar articles
The Motley Fool
December 28, 2010
Brian Orelli
Double-Digit Increase! Haven't We Learned Anything? MannKind's investors need a history lesson. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
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? mark for My Articles similar articles
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. mark for My Articles similar articles
The Motley Fool
May 31, 2011
Brian Orelli
Pay Attention, Biotech Investors Competitors and partners can't be ignored. mark for My Articles similar articles
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. mark for My Articles similar articles
IndustryWeek
October 19, 2011
FDA: A Future Innovation Partner? Could the Food and Drug Administration reform itself to help manufacturers create new medical technologies? mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
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? mark for My Articles similar articles
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. mark for My Articles similar articles
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 mark for My Articles similar articles
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. mark for My Articles similar articles
The Motley Fool
November 29, 2010
Brian Orelli
There's Still Only One Merck KGaA's oral MS drug delay is Novartis' gain. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
The Motley Fool
April 5, 2010
Brian Orelli
1 Month to Go! Is Dendreon a Buy? Only if you understand the risks. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
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 mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
The Motley Fool
November 3, 2009
Brian Orelli
A Little Distracted, Are You, Merck? The FDA rejects its latest application. mark for My Articles similar articles
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. mark for My Articles similar articles
The Motley Fool
August 9, 2010
Brian Orelli
Dendreon's in Trouble Provided you call a slap on the wrist from the FDA "trouble." mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
The Motley Fool
June 29, 2004
Charly Travers
Antegren Gets Priority Review The FDA steps up the drug's time line for approval. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
Food Processing
June 2013
Bert Slonim
Caffeine Under Siege by the FDA FDA investigation could be just the beginning of regulatory and litigation battles. mark for My Articles similar articles
The Motley Fool
September 8, 2008
Rich Duprey
The Coming Great Pharma Panic The FDA's drug warning list provides dangerously little information. mark for My Articles similar articles
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. mark for My Articles similar articles