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Reason April 2004 Todd Seavey	Regulation for Dummies A book about the FDA.
Bio-IT World September 11, 2003 John Russell	This Goose Is Better Uncooked From 'Poison Squad' to pharma watchdog, the ever-changing and controversial role of the FDA makes for fascinating history.
Pharmaceutical Executive November 1, 2011 Jill Wechsler	The Drug Shortages Struggle Clamor for critical therapies prompts probes of prices, production practices.
The Motley Fool December 31, 2010 Brian Orelli	2010 FDA Approvals and a Look Ahead Recent history can help us handicap FDA decisions.
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 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?
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.
BusinessWeek November 29, 2004 Carey & Barrett	Lessons From The Vioxx Fiasco What drugmakers, the FDA, doctors, and patients need to do.
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.
Pharmaceutical Executive June 1, 2009 Jill Wechsler	A Bigger, Bolder Agency FDA is seeking more resources to support compliance and oversight.
The Motley Fool April 26, 2011 Luke Timmerman	FDA Says Vertex Drug a Wee Bit More Effective Than Advertised; Stock Climbs Good news for Vertex?
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.
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.
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.
BusinessWeek August 26, 2010 Tom Randall	Cocktails Are Next For Cancer-Drug Makers Taking a cue from the cocktails of drugs that have made AIDS survivable, drugmakers are pursuing combination therapies against cancer.
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 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 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 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.
BusinessWeek May 21, 2007 John Carey	A Shot At Making Drugs Safer Congress could revamp the cozy ties between drugmakers and the FDA. Will it?
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 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 July 1, 2014 Jill Wechsler	Pre-emption and States' Rights Pharma backs federal standards for compassionate use, drug importing, data transparency, and track-and-trace.
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.
Pharmaceutical Executive October 1, 2012 Jill Wechsler	Changes and Challenges at FDA New user fee programs precipitate major changes at an agency under constant and intense scrutiny.
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.
BusinessWeek February 28, 2005 Capell & Carey	A Drug Watchdog To Rival The FDA Europe's agency will soon have new powers. Will it take the lead on safety?
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 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.
Pharmaceutical Executive July 1, 2013 Jill Wechsler	Seeking Supply Chain Security FDA wants pharma leaders to do more to ensure drug quality at home and abroad.
The Motley Fool January 15, 2010 Brian Orelli	Oops, Sorry About That, Pfizer The FDA says there's no problem with Spiriva after all.
Searcher June 2012 Stephanie C. Ardito	The Medical Digital: How Safe Are the Prescription Drugs we Take? Monitoring Adverse Events and Recalls For general information about prescription and clinical trial drugs, the following websites have been around for a while and have excellent reputations.
Pharmaceutical Executive June 1, 2014 Jill Wechsler	Compassionate Use Requests Complicate Drug Development Pharma, HCPs, and regulators walk tightrope in addressing early-access push while supporting biomedical R&D.
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 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.
Pharmaceutical Executive January 1, 2007 Jill Wechsler	Washington Report: A Full Plate It's going to be a busy year in Washington for the pharmaceutical industry. Drug safety, unapproved uses, e-data requirements, and a shift to personalized medicine are just a few of the hot issues on tap for 2007.
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.
HBS Working Knowledge September 24, 2007 Sean Silverthorne	The FDA: What Will the Next 100 Years Bring? The challenge for FDA leaders is to maintain morale and focus, and to back up decisions with solid data on benefits and risks to different consumer populations.
Food Engineering June 4, 2007	Congress to beef up inspection activities With one food recall after another making headlines, Congress appears intent on beefing up federal government food inspection activities.
Pharmaceutical Executive July 3, 2007 Louis A. Morris	Culture Shock The withdrawal of Vioxx signaled a sea change. Welcome to the Culture of Drug Safety. The FDA is making changes in the way it reviews drug safety. Post-marketing staff has been enlarged 25%, and new, tougher laws are on the way.
HBS Working Knowledge August 10, 2015 Michael Blanding	New Medical Devices Get To Patients Too Slowly The FDA has streamlined drug testing to ensure new therapies come to market quickly. But when it comes to life-giving medical devices, approvals seem unnecessarily slow, according to research by Ariel Dora Stern.
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.
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?
Reason September 2005 Kerry Howley	Locking Up Life-Saving Drugs U.S. prescription laws make us sicker and poorer because the system that puts drugs over the counter is driven by profits and patents.
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.
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.
Pharmaceutical Executive July 1, 2009 Jill Wechsler	Safety and Security As FDA looks to balance risks and benefits, more regulations are on the horizon.
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.
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.
Food Processing January 2007 David Joy	FDA considers functional foods There is no formal regulatory definition associated with the term "functional foods," but the FDA is soliciting information and comments on whether or not these foods should be regulated more strictly.