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Chemistry World March 6, 2014 Rebecca Trager |
Politicians accuse US food agency of illegally monitoring employees Republican leaders on two key congressional committees have concluded in a new report that the US Food and Drug Administration illegally monitored email communications sent by whistleblowers in the agency.  |
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.  |
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.  |
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 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.  |
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 February 25, 2011 Brian Orelli |
When the Companies Know, Investors Should, Too Why don't more companies preannounce FDA rejections?  |
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  |
Chemistry World November 21, 2014 Rebecca Trager |
Ranbaxy sues over withdrawn US approvals Ranbaxy -- India's largest generics manufacturer -- has sued the US Food and Drug Administration after the agency withdrew tentative approval for the company to sell generic versions of two blockbuster drugs  |
The Motley Fool August 23, 2010 Brian Orelli |
No Way to Jazz Up This Result Jazz Pharmaceuticals investors went from ecstatic to devastated in less than a week.  |
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.  |
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.  |
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.  |
InternetNews October 17, 2008 Kenneth Corbin |
Watchdog Group Takes On Telecom Immunity Law EFF fighting to overturn controversial provision of FISA Amendment Act on constitutional grounds. Follows revelations of eavesdropping excesses.  |
Pharmaceutical Executive June 1, 2009 Jill Wechsler |
A Bigger, Bolder Agency FDA is seeking more resources to support compliance and oversight.  |
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 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 August 17, 2007 Brian Orelli |
Fewer Drug Approvals? Buy! Stricter standards at the FDA could create a buying opportunity. Drug approvals are down one third this year, creating a lot of value in pharmaceutical and biotech companies. Just choose your medicines carefully.  |
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?  |
The Motley Fool December 15, 2006 Brian Lawler |
Reformatting Encysive Yet another delay from the FDA leaves investors hanging.  |
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 April 29, 2008 Brian Orelli |
Will These Drugs Get FDA Approval? Discovery Laboratories and Adolor are waiting FDA decisions on their drugs next month.  |
The Motley Fool May 30, 2008 Brian Orelli |
No Love for Antibiotics From the FDA Wyeth gets an approvable letter for its antibiotic Tygacil.  |
Food Engineering March 2, 2009 |
FDA Still Under Fire for Peanut Butter Crisis A key member of the US Senate is losing patience with the FDA over food safety issues.  |
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.  |
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.  |
Pharmaceutical Executive November 1, 2012 Jill Wechsler |
Budgets, Biosimilars, and Bad Ads While the nation was embroiled in the presidential elections, a number of important legal and regulatory issues absorbed pharmaceutical executives.  |
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.  |
Chemistry World May 14, 2015 Rebecca Trager |
FDA accused of violating drug company's freedom of speech The US Food and Drug Administration is under pressure to reconsider its policy prohibiting pharmaceutical companies from promoting 'off-label' uses of their products.  |
The Motley Fool December 22, 2003 Alyce Lomax |
Losing Faith in Inspire Delay for its dry-eye treatment leaves investors uninspired.  |
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 March 16, 2009 Brian Orelli |
Will the New FDA Chief Make Your Investments Healthy? President Obama's choice of Margaret Hamburg as head of the FDA seems to signify that the president is interested in the agency turning its focus toward protecting American's health.  |
Chemistry World May 21, 2009 Rebecca Trager |
FDA gets new chief The US Food and Drug Administration's (FDA) new commissioner, Margaret Hamburg, will be the second woman to ever lead FDA  |
The Motley Fool June 12, 2007 Brian Lawler |
Adolor Is Still Swinging The drugmaker bumps into the FDA as it pushes to do more testing of Entereg.  |
Managed Care June 2002 |
Oncologists: FDA needs to speed up approval of cancer-fighting drugs A Competitive Enterprise Institute survey of cancer specialists found that almost 8 of 10 oncologists think the FDA's approval process has "hurt their ability, at least once in their medical careers, to treat patients with the best possible care."  |
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.  |
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.  |
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.  |
The Motley Fool July 18, 2007 Brian Lawler |
More Misery for Neurochem It's hard to find another drug developer that has mishandled its correspondence with investors about its drug candidates as badly as Neurochem has over the past year.  |
Food Engineering January 6, 2008 |
Regulatory Watch Push for larger FDA food safety budget... Study urged on food from cloned animal...  |
The Motley Fool September 27, 2007 Brian Lawler |
FDA Repeats Itself With Cephalon's Fentora In the wake of a letter from Cephalon to health-care practitioners, the FDA has issued a press release and a public health advisory of the dangers of misusing the company's pain drug Fentora. Investors, take note.  |
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.  |
The Motley Fool November 16, 2009 Brian Orelli |
Music to Health-Care Investors' Ears Are faster FDA review times coming?  |
The Motley Fool February 4, 2009 Brian Orelli |
Not If, but When, for Lilly At least Lilly now knows that it's just a matter of time until the anti-clotting agent wins FDA approval.  |
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 June 2, 2004 W.D. Crotty |
FDA's Kiss of Life The FDA ignores its advisory committee and approves Allos' new drug.  |
The Motley Fool January 28, 2005 Karl Thiel |
Will the FDA Kill Biotech? Proposed legislation could spell changes across the pharmaceutical world. Investors are right to be nervous.  |
Pharmaceutical Executive December 1, 2013 |
FDA Pursues Delicate Balancing Act The Agency struggles to ensure access to needed medicines while minimizing potential risks, writes Jill Wechsler.  |
The Motley Fool June 18, 2007 Brian Lawler |
The Third Time Isn't the Charm for Encysive The approvable letter for the pulmonary arterial hypertension treatment marks the third time Thelin has failed to get full approval from the FDA. Investors, take note.  |
The Motley Fool November 8, 2007 Charly Travers |
BioMarin Tips Its Hand BioMarin Pharmaceutical awaits an FDA decision on its drug Kuvan for the treatment of phenylketonuria. The company's recent conference call implies approval is imminent.  |