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BusinessWeek July 28, 2003 John Carey	The Hundred Years' War at the FDA Philip J. Hilts's often fascinating new history of the Food & Drug Administration, Protecting America's Health: The FDA, Business, and One Hundred Years of Regulation teaches that in order to look after the public and advance medicine, there's no substitute for scientific testing.
Reason April 2004 Todd Seavey	Regulation for Dummies A book about the FDA.
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.
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.
The Motley Fool January 31, 2007 Brian Lawler	FDA Says Hurray for More Drug Safety The FDA outlines its proposal to increase drug safety. Whatever the FDA does, pharmaceutical investors should hope that its renewed interest in drug safety doesn't make the already lengthy process of bringing drugs to market any longer.
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 January 15, 2010 Brian Orelli	Oops, Sorry About That, Pfizer The FDA says there's no problem with Spiriva after all.
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 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.
Pharmaceutical Executive April 1, 2011	Off-Label But On Point? Use of off-label drugs is a balancing act for physicians, and poses even more problems for pharma. The FDA is moving slowly to help.
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 March 28, 2011 Brian Orelli	Investors Jump for Yervoy! The Food and Drug Administration approval of Bristol-Myers Squibb's Yervoy came with some surprising labeling news.
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 May 31, 2011 Brian Orelli	Pay Attention, Biotech Investors Competitors and partners can't be ignored.
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.
Pharmaceutical Executive June 1, 2009 Jill Wechsler	A Bigger, Bolder Agency FDA is seeking more resources to support compliance and oversight.
The Motley Fool December 2, 2010 Brian Orelli	A Short FDA Delay. For What? GlaxoSmithKline and Valeant aren't saying.
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.
Reason Aug/Sep 2009 Jacob Sullum	Cigarette Gag: Smokes and speech In April a bill was passed that includes a provision barring manufacturers from making any statement directed to consumers through the media that would reasonably be expected to result in consumers believing that the product is regulated and endorsed by the FDA
The Motley Fool March 16, 2010 Brian Orelli	How to Lose $114 Million in One Day You've got to be a very trusting investor to buy shares in pharmaceutical company, MannKind.
The Motley Fool January 4, 2012 Brian Orelli	This Biotech's Obese To-Do List Is Done Arena resubmits lorcaserin for FDA approval.
The Motley Fool December 8, 2010 Brian Orelli	Up 100% With Room to Fly Orexigen gets a positive FDA panel nod.
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 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.
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 October 11, 2010 Brian Orelli	What Meridia's Demise Means for Arena, VIVUS, and Orexigen Safety first ... and second ... and third...
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 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 November 29, 2010 Brian Orelli	There's Still Only One Merck KGaA's oral MS drug delay is Novartis' gain.
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 November 1, 2012 Gorsen et al.	OTC Crunch Time in California Over-the-counter products face a new wave of regulation.
The Motley Fool September 14, 2010 Luke Timmerman	Arena Obesity Drug Effective by "Slim Margin"; Shares Tumble The market is reacting negatively to news about the company's weight-loss drug.
The Motley Fool March 31, 2011 Brian Orelli	Drug Warning Labels: The Good, Bad, and Ugly Once a drug is approved, investors can't fall asleep and ignore FDA announcements about drugs. They come in different varieties, but warnings tend to be of the bad and ugly variety more often than the good.
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.
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 3, 2010 Brian Orelli	Pfizer's Hedge Pays Off FDA wants more data from Pfizer's partner, Protalix on their treatment for Gaucher disease.
The Motley Fool December 3, 2010 Brian Orelli	Obesity Drug Companies Are (Still) Risky Orexigen heads before an FDA panel.
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 February 22, 2011 Brian Orelli	A Billion-Dollar Market to Open "Very Soon" Biosimilar drugs are finally coming to the U.S.
Pharmaceutical Executive October 1, 2006 Jill Wechsler	Washington Report: After Plan B: Out of the Quagmire, into the Data The morning-after pill goes OTC, with some special requirements. But is FDA's drug information system up to the task of tracking how it is used?
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 May 26, 2009 Colleen Paulson	What's Your MO, Altria? Altria is actively supporting FDA regulation of cigarettes. Read on to see why.
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?
The Motley Fool June 3, 2011 Brian Orelli	FDA Bullies Obesity Drugmakers It's been clear for some time that the Food and Drug Administration isn't particularly fond of obesity drugs. Now it's just being a bully.
The Motley Fool September 2, 2010 Luke Timmerman	Orexigen Nabs $1B Deal With Takeda to Market Obesity Drug, Shares Climb San Diego-based Orexigen Therapeutics has found a partner to help it compete in the growing market for drugs to combat obesity, Japan-based Takeda Pharmaceutical.
The Motley Fool February 18, 2010 Brian Orelli	Still Restless for an Approval The FDA is like a box of chocolates: You never know what you're going to get -- rejection or acceptance.
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.
The Motley Fool June 29, 2010 Brian Orelli	The Final Obstacle to Your Drug Company Multibagger The dreaded FDA advisory committee meeting.
Pharmaceutical Executive May 1, 2011 John F. Brenner	Expanded Liability for Generic, Brand Manufacturers Ahead? To what extent are generics companies obligated by law to request labeling changes with FDA?
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.