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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 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 February 9, 2004 John Carey |
Drug Ads Need Stronger Medicine New FDA guidelines may not go far enough in making sure pharmaceutical ads are used appropriately. |
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. |
Reason April 2001 Ronald Bailey |
Goddamn the Pusher Man Why does everybody seem to hate the pharmaceutical industry? |
Reason October 2007 Ronald Bailey |
Is Industry-Funded Science Killing You? The overrated risks and underrated benefits of pharmaceutical research "conflicts of interest." |
BusinessWeek December 13, 2004 Carol Marie Cropper |
The Inside Dope on Drugs Watchdog Web sites can tip you off to concerns that may not be on the label. Still, before you hit the Net, start with your doctor. And don't overlook the FDA's home page. |
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. |
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. |
American Family Physician December 1, 2000 William M. Rados |
Online Information for Health Care Professionals The home page of the U.S. Food and Drug Administration has undergone a major revision. The agency's Web site, which includes more than 100,000 documents, is now easier to search and covers the full scope of the FDA's activities... |
BusinessWeek November 29, 2004 Carey & Barrett |
Lessons From The Vioxx Fiasco What drugmakers, the FDA, doctors, and patients need to do. |
Pharmaceutical Executive May 1, 2007 Kevin A. Schulman |
Kid Tested, Government Approved? Critics claim pharma is too richly rewarded for studying drugs in children. Now, several legislative proposals are on the table that just might change that. |
Pharmaceutical Executive October 1, 2011 Jill Wechsler |
Pharma's Unlikely Best Friend Sidney Wolfe has been a thorn in the side of pharma and the FDA for almost 40 years, but is also a widely respected and highly vocal critic of industry practices and products, and a visible influence on regulatory policies. |
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. |
The Motley Fool May 14, 2007 Mike Havrilla |
A Weaker Amgen Amgen's stock is trading lower after an FDA panel balked at two anemia 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. |
Salon.com May 23, 2002 Lawrence H. Diller |
A prescription for disaster The failure to test the effects in children of routinely prescribed drugs has resulted in at least one death. How many kids will die before drug companies take steps to ensure their safety? |
Pharmaceutical Executive September 1, 2008 Jeffrey S. Aronin |
The Orphan Opportunity The Orphan Drug Act was passed 25 years ago. But the challenge of actually getting rare disease drugs and therapies to patients still remains |
The Motley Fool September 6, 2005 Stephen D. Simpson |
FDA's Eye on 2 Potential Blockbusters This week, FDA advisory panels will consider the marketing approval applications of Exubera, the inhaled insulin from Pfizer/Sanofi/Nektar, and Pargluva, the dual PPAR agonist, taken in pill form, from Bristol-Myers and Merck. Investors, take note. |
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. |
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 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 May 1, 2006 Madison, Chan & Seeger |
Making the Link The FDA recognizes that a new drug standard must evolve -- one of routine, proactive safety surveillance. But post-marketing safety studies are too slow. Here's how pharmaceuticals are using claims databases to solve the problem. |
Managed Care November 2004 Martin Sipkoff |
OTC Status for Low-Dose Lovastatin Would Have Widespread Implications The FDA stands poised to approve OTC low-dose statins, following a similar change in United Kingdom. |
BusinessWeek January 21, 2010 John Carey |
Making Personalized Medicine Pay Medco and other pharmacy benefit managers say future profits depend on matching drugs to patients based on their genes. |
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. |
BusinessWeek April 11, 2005 Arlene Weintraub |
Drawing A Bead On Side Effects Drug makers are figuring out ways to make some old remedies such as Propulsid safer. |
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 May 27, 2010 Michelle Cortez |
Karo Bio's Prescription: Cheaper Drug Approval A Swedish company seeks a lower-cost review for its cholesterol drug. |
Pharmaceutical Executive June 1, 2014 Jill Wechsler |
What Price Innovation? Payers, drug plans seek clear assessment of drug value to rationalize high drug prices. |
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. |
Reason April 2004 Todd Seavey |
Regulation for Dummies A book about the FDA. |
The Motley Fool December 22, 2006 Stephen Albainy-Jenei |
Is Off-Label Off-Base? Off-label prescriptions for uses lacking scientific support account for billions in drug revenue for Eli Lilly. If the FDA takes an aggressive stance on off-label-use marketing, it could significantly shrink drug sales for companies whose revenues are derived largely from such off-label use. |
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. |
Chemistry World March 12, 2013 Anthony King |
Googling for new drug side effects Previously unknown prescription drug side effects have been revealed by the searches people do online. |
Information Today November 19, 2007 |
Thomson Healthcare Launches PDRhealth.com as Free Consumer Site The new PDRhealth.com is designed to put critical health information into the hands of consumers. |
Pharmaceutical Executive February 1, 2006 Jill Wechsler |
Washington Report: Cross-Agency Collaboration for Part D Medicare Part D gives CMS more clout over coverage, pricing, and even drug development. |
Salon.com May 16, 2001 Janelle Brown |
The poison pill The media, the government and the drug companies: They're all to blame for the fen-phen debacle, says "Dispensing With the Truth" author Alicia Mundy... |
Wired October 2006 Thomas Goetz |
The Thin Pill 75 million Americans may have something called metabolic syndrome. How Big Pharma turned obesity into a disease - then invented the drugs to cure it. |
Pharmaceutical Executive January 1, 2012 Jill Wechsler |
New Year, New Issues Look for action in 2012 on drug access, shortages, innovation, and transparency. The 800-pound gorilla in the room is the looming Supreme Court decision on the constitutionality of the Obama health reform legislation. |
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. |
Managed Care March 2005 Martin Sipkoff |
Direct-to-Consumer Ads Garner Mixed Outcomes DTC advertising's reputation as a bully may be largely overstated. There's little evidence that sales of specific drugs increase, and there may be some benefit. |
CFO Kris Frieswick |
Clinical Trials A new kind of pricing pressure puts pharmaceutical CFOs in an unfamiliar role: evangelist... |
Managed Care August 2006 Martin Sipkoff |
Off-Label Use Often Presents Conundrum for Health Plans Insurers recognize the clinical importance of off-label prescribing, but criteria are needed to avoid over-utilization. |
Bio-IT World August 13, 2003 John Rhodes |
Beyond the Blockbuster Genomics and big hits are not mutually exclusive, writes Deloitte & Touche's life sciences expert. |
Managed Care February 2007 MargaretAnn Cross |
How Much Trouble Does Health Care Marketing Cause? Whether for drugs, imaging, surgery, or emergency services, direct-to-consumer advertising sparks lively debate. |
The Motley Fool June 5, 2008 Brian Lawler |
Cancer Concerns Fuel FDA Inquiry The agency examines a class of blockbuster drugs for a link to cancer in young patients. |
Managed Care April 2004 John Carroll |
$50M for Drug Comparisons Could Produce Valuable Results The Medicare amendment adopted late last year contains a provision that could help P&T committees, not to mention consumers, evaluate competing drugs. |