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HBS Working Knowledge November 17, 2003 Martha Lagace |
The Politics of Innovation Mark B. McClellan, the new commissioner of the Food and Drug Administration, described what the FDA is doing to bridge the gap between the high cost of innovation and patients' demand for lower prices. |
AskMen.com October 30, 2015 Asandra & Palubicki |
Are Erectile Dysfunction Supplements Dangerous? Here's why erectile dysfunction supplements can be extremely dangerous. |
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. |
Managed Care January 2005 |
Cost of Coverage Forces Search For 'Alternatives' Among those turning to herbal remedies because of the cost of conventional medicine, 54% did so without either telling a conventional medical professional or disclosing use of complementary and alternative medicine during a medical visit. |
BusinessWeek November 29, 2004 Carey & Barrett |
Lessons From The Vioxx Fiasco What drugmakers, the FDA, doctors, and patients need to do. |
Reason April 2004 Todd Seavey |
Regulation for Dummies A book about the FDA. |
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. |
The Motley Fool May 3, 2005 Lawrence Meyers |
Herbs May Hurt You or Your Portfolio One day, the FDA will regulate herbal supplements. That day, drugstore and supermarket stocks will be battered. |
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 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. |
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 September 16, 2008 Brian Lawler |
Pfizer Puts Safety First Increased FDA scrutiny may motivate the pharmaceutical's new drug-safety site. |
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. |
The Motley Fool September 8, 2008 Rich Duprey |
The Coming Great Pharma Panic The FDA's drug warning list provides dangerously little information. |
The Motley Fool April 14, 2008 Brian Orelli |
Stem Cells Show Off The FDA moves closer to setting up stem cell clinical trials, setting guidelines that put treatment safety first and foremost. |
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 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 July 8, 2008 Brian Lawler |
Blockbuster Drugs Bound for Extinction? One of the biggest classes of prescription drugs, those for diabetes treatments, faces tougher FDA standards. |
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? |
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. |
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. |
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. |
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 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. |
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. |
BusinessWeek September 5, 2005 Capell & Arndt |
Drugs Get Smart Future medicines will more effectively target what ails you by tailoring treatment to your specific genetic profile. Personalized medicine will also help prevent another Vioxx. |
The Motley Fool November 27, 2006 Brian Lawler |
Pharmaxis Gets Good News From the FDA Fast-track designation gives this pharmaceutical stock a bump. |
American Family Physician December 15, 2006 |
Tips for Using Medicines Wisely A patient guide and suggestions for safe medicine use. |
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. |
Food Processing February 2008 David Joy |
Some health claims in jeopardy FDA is re-evaluating health claims for soy, antioxidant vitamins and fat-cancer. |
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. |
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 January 1, 2014 Jill Wechsler |
Pharma Challenges for 2014 Pricing and personalized medicine are key themes shaping drug development and marketing |
Pharmaceutical Executive July 30, 2007 Louis A. Morris |
Safety Net The new Culture of Drug Safety means embracing the benefit of no doubt about a product's pluses and its minuses. Pharma must learn how patients and prescribers weigh risks and how to spread the word about the advantages. |
The Motley Fool December 5, 2007 Brian Lawler |
The FDA Says It Needs a Pep Pill Drugmakers offering new treatments might be discouraged by the FDA's latest report, in which the agency makes its case for additional funding from Congress. |
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. |
BusinessWeek November 19, 2009 Catherine Arnst |
Why Drugmakers Don't Twitter The FDA has so far failed to craft rules clarifying how pharmaceutical companies can participate in online discussions. |
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. |
The Motley Fool June 3, 2009 Brian Orelli |
No More Triple-Digit Returns? If FDA decisions could be predicted easily, investors might not get to enjoy triple-digit returns, so perhaps we shouldn't be too upset about the tight-lipped nature of the FDA. |
Pharmaceutical Executive September 1, 2010 |
The Testing of the Tests FDA seeks to regulate genetic tests more actively, while encouraging diagnostic development. |
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 December 31, 2010 Brian Orelli |
2010 FDA Approvals and a Look Ahead Recent history can help us handicap FDA decisions. |
Pharmaceutical Executive November 1, 2011 Jill Wechsler |
The Drug Shortages Struggle Clamor for critical therapies prompts probes of prices, production practices. |
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 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 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. |
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? |
Pharmaceutical Executive August 1, 2014 Jill Wechsler |
Social Media Struggles Continue Tweeting limited, corrections okay, says FDA, as industry, regulators wrestle with the digital world. |
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 October 10, 2005 Stephen D. Simpson |
The FDA: Boon, Bane, Whipping Boy Everyone wants the FDA to be faster, better, and cheaper, but that may not be a credible expectation. Investors would do well to keep an eye on the FDA because its policies and pressures ultimately filter down to our medicine cabinets, wallets, and portfolios. |