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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 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.
The Motley Fool December 31, 2010 Brian Orelli	2010 FDA Approvals and a Look Ahead Recent history can help us handicap FDA decisions.
BusinessWeek December 13, 2004 John Carey	How To Prevent Another Vioxx The tragedy should spur Congress and the FDA to improve the safety of new drugs.
The Motley Fool February 14, 2011 Brian Orelli	This Biotech Is Heating Up Biosante Pharmaceuticals was up more than 9% at one point today after the company said the independent Data Monitoring Committee believed Biosante's female sexual dysfunction drug, LibiGel, was safe enough to allow the trial to continue.
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 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.
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 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.
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.
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.
Pharmaceutical Executive January 1, 2014 Jill Wechsler	Pharma Challenges for 2014 Pricing and personalized medicine are key themes shaping drug development and marketing
Pharmaceutical Executive January 1, 2011 Jill Wechsler	Politics & PDUFA Pharma companies will assess health reform, negotiate user fees and keep an eye on federal prosecutors in the year ahead.
Pharmaceutical Executive March 1, 2012 Ron Cohen	FDA's Necessary Dose of Reality There's no fast-acting salve, but there are several steps that can be taken to streamline many of the procedures at FDA. And it begins with leadership.
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 April 7, 2011 Brian Orelli	Drug Approved! But Where's the Name? AstraZeneca prepares to cash in on a minuscule market.
The Motley Fool February 23, 2005 Stephen D. Simpson	Take Two on COX-2 FDA panel recommendations breathe new life into Merck and Pfizer's COX-2 pain medications. Looking ahead, investors should give a good, long look to the drug sector.
The Motley Fool June 29, 2010 Brian Orelli	The Final Obstacle to Your Drug Company Multibagger The dreaded FDA advisory committee meeting.
Pharmaceutical Executive March 1, 2007 Jill Wechsler	Washington Report: Safety First FDA seeks to regain public trust by making drug-safety information more transparent - and to head off more stringent legislation in the process.
The Motley Fool September 17, 2010 Luke Timmerman	Cell Therapeutics OK'd to Sell Shares to Stay Alive Is the company being straight with shareholders?
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.
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 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 September 8, 2010 Jim Mueller	3 Stocks to Play Biotech Three promising ideas for investing in this exciting area.
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 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 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.
Pharmaceutical Executive May 1, 2011 Jill Wechsler	Outrage Over Drug Prices Stiff price tags draw scrutiny from Congress and consumers, and raise questions about FDA policies
Bio-IT World December 15, 2004 Kevin Davies	Patients Before Profits? After the Vioxx disaster, Pharma needs to reassure patients that they come first.
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 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.
Pharmaceutical Executive March 1, 2013 Jill Wechsler	Another Round of FDA Legislation? Pressure for action on key enforcement and regulatory issues may prompt congressional action this year.
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.
BusinessWeek November 29, 2004 Carey & Barrett	Lessons From The Vioxx Fiasco What drugmakers, the FDA, doctors, and patients need to do.
Pharmaceutical Executive December 1, 2006 Jill Wechsler	Washington Report: The New Agenda Democrats are back on top in Congress after more than a decade as underdogs. The new leaders are mapping out a broad agenda with drug pricing and access high on the list.
The Motley Fool May 26, 2011 Brian Orelli	Congress Sets Bad Precedent With AVANIR What happened to free markets?
Pharmaceutical Executive June 1, 2006 Jill Wechsler	Washington Report: Promises to Keep Congress wants pharma to meet study commitments and disclose research results, but no one is giving FDA more resources to enforce its rules.
The Motley Fool March 10, 2010 Brian Orelli	Up 160% With Room to Run You've got to love biotech and InterMune.
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 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 July 17, 2007 Brian Orelli	An Investor's Guide to the New PDUFA It's important for investors in drug companies to keep up with the latest clinical trial news, but policy changes in Washington can affect companies' bottom lines just as much.
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.
The Motley Fool December 3, 2004 Charly Travers	Sex Patch Returns to Lab FDA panel's safety concerns have sidetracked Proctor & Gamble's Intrinsa.
Reason April 2008 Ronald Bailey	Medical Speech As a 1997 law expires, the FDA is mulling a plan allowing companies to disseminate unabridged reprints of "truthful and non-misleading" medical journal articles describing "off-label" uses of approved medications to physicians.
BusinessWeek March 7, 2005 John Carey	Side Effects Of The Drug Scares New fears give rise to a more honest look at the risks for a pill-popping nation.
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.
The Motley Fool August 9, 2010 Jim Mueller	3 Stocks to Play Biotech Three promising ideas for investing in this exciting area.
Pharmaceutical Executive June 1, 2007 Clinton & Wechsler	The View From Inside Commissioner Andrew von Eschenbach on drug safety, DTC advertising, FDA's culture, and how the agency plans to bring itself into the age of molecular medicine.
The Motley Fool June 18, 2010 Brian Orelli	Double the Approvals! Double the Fun! These twins will take it. sanofi-aventis and Novartis both received FDA approvals for their cancer drugs yesterday.