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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. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
Pharmaceutical Executive
January 1, 2006
Lou Morris
Back Page: Nailing Down DTC Promotion Before the FDA and industry can find a solution to direct to consumer promotion, they need to nail down the problem. mark for My Articles similar articles
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. mark for My Articles similar articles
Pharmaceutical Executive
October 1, 2005
Patrick Clinton
From the Editor: No Substitutes Don't use surrogate measures in clinical drug trials, says a major industry critic. OK, but don't the critics base a lot of their points on surrogate measures, too? mark for My Articles similar articles
Pharmaceutical Executive
April 1, 2006
Diane West
Media Spend Trends: Change the Channel Drug marketers still spend lots of money. But they aim at PhRMA loopholes. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
American Family Physician
February 15, 2006
Liz Smith
Newsletter FDA Announces New Prescription Drug Information Format... ASTM International Develops Continuity of Care Record... HHS Launches Project to Test Electronic Prescribing for Medicare Part D... etc. mark for My Articles similar articles
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. mark for My Articles similar articles
Pharmaceutical Executive
April 1, 2007
McCook & Daniels
Making the Switch More companies are using Rx-to-OTC switches to extend a brand's life cycle. Prilosec did it. Here, experts dish on how you can do it too. mark for My Articles similar articles
Pharmaceutical Executive
November 1, 2012
Sue Barrowcliffe
Real World Insights Commercial teams as well as patients can benefit from managed access programs, which are designed to provide access to medicines outside of the clinical and commercial setting, for patients who have no other available treatment options. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
BusinessWeek
November 29, 2004
Carey & Barrett
Lessons From The Vioxx Fiasco What drugmakers, the FDA, doctors, and patients need to do. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
The Motley Fool
August 22, 2007
Brian Orelli
Regulating the Drug Pushers The FDA might get a little tougher on drug ads, following a report that they may not be watching advertisers claims closely enough, or warning patients about side effects strongly enough. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
Pharmaceutical Executive
December 1, 2005
Patrick Clinton
PharmExec's 2006 Forecast The 2006 pharmaceutical industry is under assault from Congress, the press and the public, add a complex government program that will unimaginably change industry economics, and subtract revenues from off-patent products. mark for My Articles similar articles
Reason
Aug/Sep 2007
Kerry Howley
Dying for Lifesaving Drugs Will desperate patients destroy the pharmaceutical system that produces tomorrow's treatments? mark for My Articles similar articles
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? mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
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... mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
The Motley Fool
September 8, 2008
Rich Duprey
The Coming Great Pharma Panic The FDA's drug warning list provides dangerously little information. mark for My Articles similar articles
Pharmaceutical Executive
March 1, 2006
Lou Morris
Backpage: Warning Letter A press release describes the existence of a new Patient Counseling Information section. Drug labels have contained a patient information section within the precautions section. The suggestion that this section is new is false and misleading. mark for My Articles similar articles
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. mark for My Articles similar articles
Fast Company
February 2014
Jeff Chu
Apple Retail at a Glance Facts and figures about Apple retail numbers. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
Pharmaceutical Executive
May 1, 2007
Weiner & Hovde
Critical Mass for Critical Path? Everyone agrees that it's the road to pharma's future, but no one's rushing to take it. Yet with growing FDA advocacy and new advances in biomarkers and drug-disease modeling, the rewards of collaboration now look greater than the risks. mark for My Articles similar articles
The Motley Fool
September 16, 2008
Brian Lawler
Pfizer Puts Safety First Increased FDA scrutiny may motivate the pharmaceutical's new drug-safety site. mark for My Articles similar articles
BusinessWeek
April 25, 2005
Catherine Arnst
When Patients Say: Don't Ban My Drug Emotional lobbying can keep a treatment on the market despite serious side effects. mark for My Articles similar articles
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? mark for My Articles similar articles
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? mark for My Articles similar articles
The Motley Fool
January 14, 2008
Brian Lawler
Score One for Dendreon and Disclosure A prestigious journal supports Dendreon's potential prostate cancer treatment, and makes a compelling case for more FDA disclosure. mark for My Articles similar articles
Investment Advisor
December 2005
Greg B. Scott
Buying The Future Prudent investing in biotechnology can offer great returns for clients. It's also the wave of the future. Armed with a basic understanding of the dynamics of the industry and the valuation inflection points, intelligent investors can make significant returns. mark for My Articles similar articles
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. mark for My Articles similar articles
Pharmaceutical Executive
January 1, 2006
Clinton & Wechsler
What Ever Happened to Critical Path FDA's ambitious program to improve drug development disappeared from view almost as soon as it was announced. Suddenly, it's back, but is it here to stay? mark for My Articles similar articles
The Motley Fool
December 31, 2010
Brian Orelli
2010 FDA Approvals and a Look Ahead Recent history can help us handicap FDA decisions. mark for My Articles similar articles
Information Today
January 29, 2001
Susan Detwiler
Drugfacts.com Portal Launched to Fill a Niche On December 4, 2000, Wolters Kluwer International Health & Science introduced DRUGFACTS.com, a new portal aimed at pharmacists and drug information professionals... mark for My Articles similar articles
Pharmaceutical Executive
February 1, 2006
Bryan Luce
Back Page: Taking Hold of the Wheel Healthcare decision makers do not consistently consider drugs' value. FDA needs to be pressured to change its stance on communicating economic evidence. mark for My Articles similar articles
Pharmaceutical Executive
August 1, 2012
Jill Wechsler
Fleshing Out FDASIA Medical apps, e-submissions, counterfeit drugs, and imports tucked into fairly "clean" user-fee renewal legislation. In late June leading legislators reached across party lines to quickly approve the Food and Drug Administration Safety and Innovation Act. mark for My Articles similar articles