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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 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.
Pharmaceutical Executive June 1, 2007 Patrick Clinton	From the Editor: Not His Problem In the current climate, who's going to get doctors to take on the work of making good decisions and occasionally the responsibility for having made a bad one?
Pharmaceutical Executive January 1, 2007	Thoughtleader: Peter Pitts. DrugWonks.com Here, the chief voice of a blog hosted by the non-profit Center for Medicine in the Public Interest urges pharma to continuously plug its positions and get politics out of science, and offers some perspective on important regulatory reforms facing the FDA.
The Motley Fool September 18, 2007 Brian Orelli	PDUFA Reauthorization: Almost There Much to the applause of drug makers and those who invest in them, the Prescription Drug User Fee Act reauthorization looks like it could come out of a Congressional conference committee as early as this week.
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.
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.
The Motley Fool July 29, 2010 Brian Orelli	This FDA Panel Isn't Brilliant Why does AstraZeneca's blood thinner Brilinta work better outside the U.S. than here at home? The Food and Drug Administration's advisory panel didn't seem to have a good explanation, but they didn't appear to care much, either.
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 22, 2010 Matt Koppenheffer	Arena Pharmaceuticals Shares Plunged: What You Need to Know Shares of biopharma company Arena Pharmaceuticals dipped as much as 13% in intraday trading on massive volume.
The Motley Fool March 8, 2010 Brian Orelli	Really? A 59% Share Price Jump for That? Justified or not, InterMune skyrockets ahead of an FDA panel meeting.
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 April 1, 2011 Travis Hoium	Optimer Pharmaceuticals Shares Popped: What You Need to Know Shares of Optimer Pharmaceuticals jumped 12% today after positive news from the FDA was released.
The Motley Fool September 29, 2011 Brian Orelli	Investors Guide to the New PDUFA Changes are in the air for drugmakers and the FDA.
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 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 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.
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 December 8, 2010 Brian Orelli	Up 100% With Room to Fly Orexigen gets a positive FDA panel nod.
The Motley Fool October 11, 2010 Brian Orelli	What Meridia's Demise Means for Arena, VIVUS, and Orexigen Safety first ... and second ... and third...
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 November 19, 2010 Brian Orelli	Up 95%, but Still Risky as Heck That's an understatement for MELA Sciences.
The Motley Fool May 13, 2011 Brian Orelli	FDA Advisory Panel Positive! Shares Punished. Despite the positive recommendation, investors aren't convinced BioMimetic's Augment will be approved.
The Motley Fool June 25, 2010 Brian Orelli	Mark Your Calendars: Obesity Drugs Take Center Stage Orexigen Therapeutics has been given an FDA advisory committee meeting date, completing the dates for the trio of obesity drugs up for review.
The Motley Fool June 20, 2011 Brian Orelli	See Drug, Approve Drug An approval of Regeneron's macular degeneration Eylea looks likely.
The Motley Fool March 10, 2010 Brian Orelli	Up 160% With Room to Run You've got to love biotech and InterMune.
Pharmaceutical Executive January 1, 2006 Jill Wechsler	Washington Report: PDUFA Blues The Prescription Drug User Fee Act is up for reauthorization. Let the games begin.
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.
The Motley Fool November 17, 2010 Brian Orelli	52 Years Down, 1 Month to Go Lupus treatment Benlysta moves closer to approval.
The Motley Fool December 3, 2010 Travis Hoium	Orexigen Therapeutics Shares Plunged: What You Need to Know Shares of biopharmaceutical company Orexigen Therapeutics fell 10% today after a Food and Drug Administration announcement.
The Motley Fool June 3, 2011 Luke Timmerman	Orexigen, Facing High Hurdle at FDA, Puts Obesity Drug Development on Hold The close attention paid to safety makes this drug difficult to get right.
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.
The Motley Fool September 16, 2010 Brian Orelli	Abbott's Product Line May Get Thinner Not that it needs the obesity drug.
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.
The Motley Fool March 27, 2008 Brian Lawler	A Drugmaker's Candid Thoughts on the FDA Cardiome updates investors on its top two drugs.
The Motley Fool April 28, 2011 Brian Orelli	Victory for Victrelis Merck's hepatitis C drug moves one step closer to FDA approval.
The Motley Fool December 6, 2010 Brian Orelli	3-Month Delay? No Problem! Investors shrug off HGS' Benlysta delay. The Food and Drug Administration's delaying its decision on whether to approve Human Genome Sciences and GlaxoSmithKline's Benlysta shouldn't come as much of a surprise.
The Motley Fool August 6, 2007 Brian Orelli	Congress' Delay May Hurt Drugmakers The reauthorization of the Prescription Drug User Fee Act is delayed. If you're an investor in drug companies, now might be a good time to call your representatives and senators.
The Motley Fool June 8, 2010 Brian Orelli	Injecting Uncertainty Into the Multiple Sclerosis Market Novartis' oral MS drug could be a blockbuster -- if it can get past the FDA.
The Motley Fool July 13, 2010 Brian Orelli	A Triple Delight: 3 Stocks All Up More Than 10% What's good for the obese goose is good for the gander when it comes to new drug treatments for losing weight.
The Motley Fool August 14, 2008 Brian Lawler	A Potentially Painless PDUFA Date King Pharmaceuticals and Pain Therapeutics get an appointment with the FDA.
The Motley Fool April 11, 2008 Brian Lawler	Amgen's Unsurprising Delay The FDA extends its review of an Amgen drug candidate.
The Motley Fool June 29, 2010 Brian Orelli	The Final Obstacle to Your Drug Company Multibagger The dreaded FDA advisory committee meeting.
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.
The Motley Fool October 8, 2007 Brian Orelli	New FDA Regulations for Drugmakers To deal with a growing backlog of pending applications, the FDA plans to stop its first-come, first-served system.
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 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 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.
The Motley Fool September 21, 2010 Brian Orelli	Double-Digit Weight Loss, Double-Digit Share Increase Vivus is down, but apparently not out.